Citations within the context of their regulations
Review the enforcement history for every citation given out with the Biologics sector.
21 CFR 680.1(b)(2)(iii) - (iii) Mold manufacturers shall maintain written standard operating procedures, developed by a qua...
21 CFR 600.15 - Temperatures during shipment.
21 CFR 600.14(c) - (c) When do I report under this section? You should report a biological product deviation as soo...
21 CFR 600.14(a)(1) - (1) You, the manufacturer who holds the biological product license and who had control over the p...
21 CFR 600.11(h) - (h) Containers and closures. All final containers and closures shall be made of material that wi...
21 CFR 600.11(a) - (a) Work areas. All rooms and work areas where products are manufactured or stored shall be kept...
21 CFR 600.11(b) - (b) Equipment. Apparatus for sterilizing equipment and the method of operation shall be such as ...
21 CFR 600.10(b) - (b) Personnel. Personnel shall have capabilities commensurate with their assigned functions, a t...
21 CFR 600.12(c) - (c) Records of sterilization of equipment and supplies. Records relating to the mode of steriliz...
21 CFR 600.12(a) - (a) Maintenance of records. Records shall be made, concurrently with the performance, of each st...
21 CFR 600.12(b)(1) - (1) General. Records shall be retained for such interval beyond the expiration date as is necess...
21 CFR 600.12(b)(2) - (2) Records of recall. Complete records shall be maintained pertaining to the recall from distri...
21 CFR 600.80(b) - (b) Review of adverse experiences. Any person having a biologics license under § 601.20 of this ...
21 CFR 600.80(c) - (c) Reporting requirements
21 CFR 600.80(c)(1)(i) - (i) Postmarketing 15-day “Alert reports”. The applicant must report each adverse experience that...
21 CFR 600.80(c)(1)(ii) - (ii) Postmarketing 15-day “Alert reports”—followup. The applicant must promptly investigate all ...
21 CFR 600.80(c)(1)(iii) - (iii) Submission of reports. The requirements of paragraphs (c)(1)(i) and (c)(1)(ii) of this sec...
21 CFR 600.80(c)(2)(i) - (i) The applicant must report each adverse experience not reported under paragraph (c)(1)(i) of t...
21 CFR 600.80(c)(2)(ii) - (ii) Each periodic report is required to contain:
21 CFR 600.81 - Distribution reports.
21 CFR 601.12(d) - (d) Changes to be described in an annual report (minor changes).
21 CFR 601.12(b) - (b) Changes requiring supplement submission and approval prior to distribution of the product mad...
21 CFR 601.12(c) - (c) Changes requiring supplement submission at least 30 days prior to distribution of the product...
21 CFR 601.12(f)(1) - (1) Labeling changes requiring supplement submission—FDA approval must be obtained before distrib...
21 CFR 606.20(c) - (c) Persons whose presence can adversely affect the safety and purity of the products shall be ex...
21 CFR 606.20(b) - (b) The personnel responsible for the collection, processing, compatibility testing, storage or d...
21 CFR 606.40(b) - (b) Provide adequate lighting, ventilation and screening of open windows and doors.
21 CFR 606.40(c) - (c) Provide adequate, clean, and convenient handwashing facilities for personnel, and adequate, c...
21 CFR 606.40 - Facilities.
21 CFR 606.40(a)(1) - (1) Private and accurate examinations of individuals to determine their eligibility as blood dono...
21 CFR 606.40(a)(2) - (2) The withdrawal of blood from donors with minimal risk of contamination, or exposure to activi...
21 CFR 606.40(a)(3) - (3) The storage of blood or blood components pending completion of tests.
21 CFR 606.40(a)(6) - (6) The quarantine storage, handling and disposition of products and reagents not suitable for us...
21 CFR 606.40(a)(7) - (7) The orderly collection, processing, compatibility testing, storage and distribution of blood ...
21 CFR 606.40(a)(9) - (9) The orderly conduction of all packaging, labeling and other finishing operations.
21 CFR 606.40(d)(2) - (2) Blood and blood components not suitable for use or distribution.
21 CFR 606.60(a) - (a) Equipment used in the collection, processing, compatibility testing, storage and distribution...
21 CFR 606.60(b) - (b) Equipment that shall be observed, standardized and calibrated with at least the following fre...
21 CFR 606.65(c) - (c) Representative samples of each lot of the following reagents or solutions shall be tested on ...
21 CFR 606.65(e) - (e) Supplies and reagents shall be used in a manner consistent with instructions provided by the ...
21 CFR 606.65 - Supplies and reagents.
21 CFR 606.110(b) - (b) Plasmapheresis of donors who do not meet the donor requirements of §§ 630.10, 630.15, 640.64 ...
21 CFR 606.110(a) - (a) The use of plateletpheresis and leukapheresis procedures to obtain a product for a specific r...
21 CFR 606.100(c) - (c) All records pertinent to the lot or unit maintained pursuant to these regulations shall be re...
21 CFR 606.100(a) - (a) In all instances, except clinical investigations, standard operating procedures shall comply ...
21 CFR 606.100(b) - (b) Establishments must establish, maintain, and follow written standard operating procedures for...
21 CFR 606.100(b)(1) - (1) Criteria used to determine donor eligibility, including acceptable medical history criteria.
21 CFR 606.100(b)(10) - (10) Storage temperatures and methods of controlling storage temperatures for all blood products ...
21 CFR 606.100(b)(12) - (12) Criteria for determining whether returned blood is suitable for reissue.
21 CFR 606.100(b)(13) - (13) Procedures used for relating a unit of blood or blood component from the donor to its final ...
21 CFR 606.100(b)(14) - (14) Quality control procedures for supplies and reagents employed in blood collection, processin...
21 CFR 606.100(b)(15) - (15) Schedules and procedures for equipment maintenance and calibration.
21 CFR 606.100(b)(16) - (16) Labeling procedures, including safeguards to avoid labeling mixups.
21 CFR 606.100(b)(18) - (18) Procedures for preparing recovered plasma, if performed, including details of separation, po...
21 CFR 606.100(b)(19) - (19) Procedures under §§ 610.46 and 610.47 of this chapter:
21 CFR 606.100(b)(2) - (2) Methods of performing donor qualifying tests and measurements, including minimum and maximum ...
21 CFR 606.100(b)(20) - (20) Procedures for donor deferral as prescribed in § 610.41 of this chapter.
21 CFR 606.100(b)(21) - (21) Procedures for donor notification and notification of the referring physician of an autologo...
21 CFR 606.100(b)(22) - (22) Procedures to control the risks of bacterial contamination of platelets, including all steps...
21 CFR 606.100(b)(3) - (3) Solutions and methods used to prepare the site of phlebotomy to give maximum assurance of a s...
21 CFR 606.100(b)(4) - (4) Method of accurately relating the product(s) to the donor.
21 CFR 606.100(b)(5) - (5) Blood collection procedure, including in-process precautions taken to measure accurately the ...
21 CFR 606.100(b)(6) - (6) Methods of component preparation, including any time restrictions for specific steps in proce...
21 CFR 606.100(b)(7) - (7) All tests and repeat tests performed on blood and blood components during manufacturing.
21 CFR 606.100(b)(8) - (8) Pretransfusion testing, where applicable, including precautions to be taken to identify accur...
21 CFR 606.100(b)(9) - (9) Procedures for investigating adverse donor and recipient reactions.
21 CFR 606.120(a) - (a) Labeling operations shall be separated physically or spatially from other operations in a man...
21 CFR 606.120(b)(2) - (2) Each type of label representing different products shall be stored and maintained in a manner...
21 CFR 606.122 - Circular of information.
21 CFR 606.121(b) - (b) The label provided by the collecting facility and the initial processing facility must not be...
21 CFR 606.121(f) - (f) Blood and blood components determined to be unsuitable for transfusion must be prominently la...
21 CFR 606.121(h) - (h) The following additional information must appear on the label for blood and blood components ...
21 CFR 606.121(c)(1) - (1) The proper name of the product in a prominent position, with any appropriate modifiers and at...
21 CFR 606.121(c)(11) - (11) If the product is intended for further manufacturing use, a statement listing the results of...
21 CFR 606.121(c)(12) - (12) The blood and blood components must be labeled in accordance with § 610.40 of this chapter, ...
21 CFR 606.121(c)(13) - (13) The container label of blood or blood components intended for transfusion must bear encoded ...
21 CFR 606.121(c)(2) - (2) The name, address, unique facility identifier, and, if a licensed product, the license number...
21 CFR 606.121(c)(7) - (7) The recommended storage temperature (in degrees Celsius).
21 CFR 606.121(c)(8) - (8) If the product is intended for transfusion, the statements:
21 CFR 606.121(c)(9) - (9) If the product is intended for transfusion or as is otherwise appropriate, the ABO group and ...
21 CFR 606.121(c)(4)(i) - (i) The expiration date, including the day, month, and year, and, if the dating period for the pr...
21 CFR 606.121(c)(4)(ii) - (ii) If Source Plasma intended for manufacturing into noninjectable products is pooled, the expir...
21 CFR 606.121(e) - (e) Container label requirements for particular products or groups of products
21 CFR 606.121(e)(5) - (5) Source Plasma labels must include the following information:
21 CFR 606.145(d) - (d) In the event that a contaminating organism is identified under paragraph (b) or (c) of this s...
21 CFR 606.145(b) - (b) In the event that a blood collection establishment identifies platelets as bacterially contam...
21 CFR 606.145(a) - (a) Blood collection establishments and transfusion services must assure that the risk of bacteri...
21 CFR 606.145(c) - (c) In the event that a transfusion service identifies platelets as bacterially contaminated, the...
21 CFR 606.140(a) - (a) The establishment of scientifically sound and appropriate specifications, standards and test ...
21 CFR 606.140(c) - (c) Adequate identification and handling of all test samples so that they are accurately related ...
21 CFR 606.140(b) - (b) Adequate provisions for monitoring the reliability, accuracy, precision and performance of la...
21 CFR 606.151(e) - (e) Procedures to expedite transfusion in life-threatening emergencies. Records of all such incid...
21 CFR 606.151(a) - (a) A method of collecting and identifying the blood samples of recipients to ensure positive ide...
21 CFR 606.151(d) - (d) A provision that, if the unit of donor's blood has not been screened by a method that will de...
21 CFR 606.160(d) - (d) Records shall be retained for such interval beyond the expiration date for the blood or blood...
21 CFR 606.160(c) - (c) A donor number shall be assigned to each accepted donor, which relates the unit of blood coll...
21 CFR 606.160(a)(1) - (1) Records shall be maintained concurrently with the performance of each significant step in the...
21 CFR 606.160(a)(2) - (2) Appropriate records shall be available from which to determine lot numbers of supplies and re...
21 CFR 606.160(b) - (b) Records shall be maintained that include, but are not limited to, the following when applicab...
21 CFR 606.160(b)(6) - (6) Transfusion reaction reports and complaints, including records of investigations and followup...
21 CFR 606.160(e)(1) - (1) Establishments must maintain at each location a record of all donors found to be ineligible o...
21 CFR 606.160(e)(2) - (2) Establishments must maintain at all locations operating under the same license or under commo...
21 CFR 606.170(a) - (a) Records shall be maintained of any reports of complaints of adverse reactions regarding each ...
21 CFR 606.170(b) - (b) When a complication of blood collection or transfusion is confirmed to be fatal, the Director...
21 CFR 606.171(a) - (a) Who must report under this section? You, a licensed manufacturer of blood and blood componen...
21 CFR 606.171 - Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishm...
21 CFR 606.165(a) - (a) Distribution and receipt procedures shall include a system by which the distribution or recei...
21 CFR 606.165(b) - (b) Distribution records shall contain information to readily facilitate the identification of th...
21 CFR 606.165(c) - (c) Receipt records shall contain the name and address of the collecting facility, date received,...
21 CFR 610.1 - Tests prior to release required for each lot.
21 CFR 610.18(b) - (b) Identity and verification. Each culture shall be clearly identified as to source strain. A c...
21 CFR 610.40(e) - (e) Further testing. You must further test each donation, including autologous donations, found ...
21 CFR 610.40(f) - (f) Testing responsibility. Required testing under this section, must be performed by a laborato...
21 CFR 610.40(b) - (b) Testing using one or more licensed, approved, or cleared screening tests. To perform testing...
21 CFR 610.40(c)(2) - (2) Medical device.
21 CFR 610.40(h) - (h) Restrictions on shipment or use —
21 CFR 610.40(h)(2)(ii) - (ii) You must not ship or use human blood or blood components that have a reactive screening test...
21 CFR 610.40(a) - (a) Human blood and blood components
21 CFR 610.40(a)(2) - (2) Test each donation for evidence of infection due to the relevant transfusion-transmitted infe...
21 CFR 610.40(d)(4) - (4) Each autologous donation must be labeled as required under § 606.121 of this chapter and with...
21 CFR 610.41 - Donor deferral.
21 CFR 610.46(a) - (a) If you are an establishment that collects Whole Blood or blood components, including Source P...
21 CFR 610.46(a)(1) - (1) Within 3 calendar days after a donor tests reactive for evidence of human immunodeficiency vi...
21 CFR 610.46(a)(2) - (2) You must perform further testing for HIV as required under § 610.40(e) of this chapter on the...
21 CFR 610.46(b) - (b) If you are a consignee of Whole Blood or blood components, including Source Plasma and Source...
21 CFR 610.46(b)(3) - (3) When further testing for HIV is positive or when the screening test is reactive and further t...
21 CFR 610.47 - Hepatitis C virus (HCV) “lookback” requirements.
21 CFR 610.47(a) - (a) If you are an establishment that collects Whole Blood or blood components, including Source P...
21 CFR 610.47(a)(1) - (1) Within 3 calendar days after a donor tests reactive for evidence of hepatitis C virus (HCV) i...
21 CFR 610.47(a)(3) - (3) You must notify consignees of the results of further testing for HCV, or the results of the r...
21 CFR 610.47(b) - (b) If you are a consignee of Whole Blood or blood components, including Source Plasma or Source ...
21 CFR 610.47(b)(3) - (3) When the further testing for HCV is positive or when the screening test is reactive and furth...
21 CFR 610.53(b) - (b) Table of dating periods. In using the table in this paragraph, when a product in column A is...
21 CFR 610.60 - Container label.
21 CFR 610.63 - Divided manufacturing responsibility to be shown.
21 CFR 630.5(d) - (d) Must rapid emergency medical services be available ? Establishments that collect blood or blo...
21 CFR 630.5(c)(1)(i) - (i) The responsible physician may delegate to a physician substitute or other trained person any ...
21 CFR 630.30(a) - (a) When is a donation suitable ? A donation is suitable when:
21 CFR 630.30(a)(1) - (1) The donor is not currently deferred from donation as determined by review of the records of d...
21 CFR 630.30(a)(2) - (2) The results in accordance with §§ 630.10 through 630.25 indicate that the donor is in good he...
21 CFR 630.30(a)(3) - (3) The results in accordance with § 630.10(e) indicate that the donor is free from risk factors ...
21 CFR 630.30(b)(1) - (1) You must not release the donation for transfusion or further manufacturing use unless it is a...
21 CFR 630.30(b)(2) - (2) You must defer the donor when a donation is determined to be unsuitable based on the criteria...
21 CFR 630.15(b)(3) - (3) Weight. You must weigh a donor at each donation.
21 CFR 630.15(b)(6) - (6) Deferral of donors due to red blood cell loss.
21 CFR 630.15(b)(1) - (1) Medical history and physical examination
21 CFR 630.15(b)(1)(ii) - (ii) The responsible physician must examine the donor for medical conditions that would place the...
21 CFR 630.15(b)(2) - (2) What requirements apply to obtaining informed consent ?
21 CFR 630.15(b)(2)(iii) - (iii) The responsible physician must explain the risks and hazards of the procedure to the donor....
21 CFR 630.10(h) - (h) What must you do when a donor is not eligible ? You must not collect blood or blood component...
21 CFR 630.10(c) - (c) When must you determine the eligibility of a donor ? You must determine donor eligibility on ...
21 CFR 630.10(b) - (b) What educational material must you provide to the donor before determining eligibility ? You ...
21 CFR 630.10(e) - (e) How do you assess the donor's medical history ? Before collection you must conduct a medical ...
21 CFR 630.10(e)(1) - (1) Factors that make the donor ineligible to donate because of an increased risk for, or evidenc...
21 CFR 630.10(e)(2) - (2) Other factors that make the donor ineligible to donate. A donor is ineligible to donate when ...
21 CFR 630.10(g)(1) - (1) Proof of identity and postal address. You must obtain proof of identity of the donor and a p...
21 CFR 630.10(g)(2) - (2) Donor's acknowledgement
21 CFR 630.10(g)(2)(ii) - (ii) The donor acknowledgement must not include any exculpatory language through which the donor ...
21 CFR 630.10(f)(4) - (4) Pulse. The donor's pulse must be regular and between 50 and 100 beats per minute. A donor wi...
21 CFR 630.10(f)(3) - (3) Hemoglobin or hematocrit determination
21 CFR 630.10(f)(3)(i)(B) - (B) Male allogeneic donors must have a hemoglobin level that is equal to or greater than 13.0 gra...
21 CFR 630.10(f)(6)(i) - (i) The donor's phlebotomy site must be free of infection, inflammation, and lesions; and
21 CFR 630.10(f)(6)(ii) - (ii) The donor's arms and forearms must be free of punctures and scars indicative of injected dru...
21 CFR 630.10(d)(2) - (2) Assure that the interval since the donor's last donation is appropriate;
21 CFR 630.10(d)(4) - (4) Perform a physical assessment of the donor.
21 CFR 630.40(a) - (a) Notification of donors. You, an establishment that collects blood or blood components, must ...
21 CFR 630.40(c) - (c) Time period for notification. You must make reasonable attempts to notify the donor within 8...
21 CFR 630.40(d)(1) - (1) You also must provide the following information to the referring physician of an autologous d...
21 CFR 630.40(d)(2) - (2) You must make reasonable attempts to notify the autologous donor's referring physician within...
21 CFR 630.40(b)(1) - (1) That the donor is deferred or determined not to be eligible for donation and the reason for t...
21 CFR 630.40(b)(2) - (2) Where appropriate, the types of donation of blood or blood components that the donor should n...
21 CFR 630.40(b)(3) - (3) Where applicable, the results of tests for evidence of infection due to relevant transfusion-...
21 CFR 630.40(b)(4) - (4) Where appropriate, information concerning medical followup and counseling.
21 CFR 640.4(f) - (f) Prevention of contamination of the blood. The skin of the donor at the site of phlebotomy sh...
21 CFR 640.4(h) - (h) Storage. Whole Blood must be placed in storage at a temperature between 1 and 6 °C immediate...
21 CFR 640.4(g)(3) - (3) All containers for all samples shall bear the donor's identification before collecting the sa...
21 CFR 640.2(c)(3) - (3) The blood has been stored continuously at 1 to 6 °C and shipped between 1 and 10 °C;
21 CFR 640.5(e) - (e) Inspection. Whole Blood shall be inspected visually during storage and immediately prior to ...
21 CFR 640.15(a) - (a) One or more segments shall be provided with each unit of Whole Blood or Red Blood Cells when ...
21 CFR 640.16(b) - (b) Sterile system. All surfaces that come in contact with the red cells shall be sterile and py...
21 CFR 640.11(b) - (b) Inspection. The product shall be inspected immediately after separation of the plasma, perio...
21 CFR 640.11(a) - (a) Storage. Immediately after processing, the Red Blood Cells shall be placed in storage and ma...
21 CFR 640.25(a) - (a) Storage. Immediately after resuspension, Platelets shall be placed in storage at the selecte...
21 CFR 640.25(b) - (b) Quality control testing
21 CFR 640.25(b)(4) - (4) If the results of the quality control testing indicate that the product does not meet the pre...
21 CFR 640.24(b) - (b) Immediately after collection, the whole blood or plasma shall be held in storage between 20 a...
21 CFR 640.21(e) - (e) Frequency of plateletpheresis collection.
21 CFR 640.21(f) - (f) Deferral of plateletpheresis donors due to red blood cell loss.
21 CFR 640.21(g) - (g) The responsible physician must obtain the informed consent of a plateletpheresis donor on the...
21 CFR 640.21(a) - (a) Establishments must determine the eligibility of donors of platelets derived from Whole Blood...
21 CFR 640.34(b) - (b) Fresh Frozen Plasma. Fresh frozen plasma shall be prepared from blood collected by a single ...
21 CFR 640.34(c) - (c) Liquid Plasma. Liquid Plasma shall be separated from the red blood cells and shall be stored...
21 CFR 640.34(g)(1) - (1) The final product shall be inspected immediately after separation of the plasma and shall not...
21 CFR 640.34(g)(2) - (2) With the exception of Platelet Rich Plasma and Liquid Plasma the final product shall be inspe...
21 CFR 640.31(b) - (b) Collection establishments must determine the eligibility of plasmapheresis donors in accordan...
21 CFR 640.31 - Eligibility of donors.
21 CFR 640.52 - Collection of source material.
21 CFR 640.56(d) - (d) If the average potency level of antihemophilic factor in the containers tested is less than 8...
21 CFR 640.66 - Immunization of donors.
21 CFR 640.67 - Laboratory tests.
21 CFR 640.68(b) - (b) Final containers. Final containers used for Source Plasma, whether integrally attached or se...
21 CFR 640.64(e) - (e) Prevention of contamination of the blood and plasma. The skin of the donor at the site of ph...
21 CFR 640.73 - Reporting of fatal donor reactions.
21 CFR 640.76(c) - (c) Relabeling. If Source Plasma is required to be relabeled as “Source Plasma Salvaged” under p...
21 CFR 640.76(a)(2) - (2) Source Plasma intended for manufacture into injectable products that is exposed inadvertently...
21 CFR 640.69(b) - (b) Storage. Immediately after filling, plasma intended for manufacturing into injectable produc...
21 CFR 640.72(d) - (d) If a donor has a reaction while on the plasmapheresis premises, or a donor reaction is report...
21 CFR 640.72(b) - (b) Each donor record must be directly cross-referenced to the unit(s) of Source Plasma associate...
21 CFR 640.72(a)(1) - (1) Documentation shall be available to ensure that the shipping temperature requirements of § 60...
21 CFR 640.72(a)(2) - (2)
21 CFR 640.72(a)(3) - (3) The original or a clear copy or other durable record which may be electronic of the donor's c...
21 CFR 640.72(a)(4) - (4) Records of the medical history and physical examination of the donor conducted in accordance ...
21 CFR 640.65(b)(3) - (3) A donor identification system shall be established that positively identifies each donor and ...
21 CFR 640.65(b)(4) - (4) The amount of whole blood, not including anticoagulant, removed from a donor during a manual ...
21 CFR 640.65(b)(8) - (8) The volume of plasma collected during an automated plasmapheresis collection procedure shall ...
21 CFR 640.65(b)(1)(i) - (i) Except as provided under § 630.25 of this chapter, the responsible physician must draw a samp...
21 CFR 640.65(b)(1)(iii) - (iii) A repeat donor from whom the plasmapheresis center is unable to obtain a sample for testing...
21 CFR 640.65(b)(2)(i) - (i) Except as provided under § 630.25 of this chapter, the responsible physician must review the ...
21 CFR 640.81(c) - (c) Microbial contamination. All processing steps shall be conducted in a manner to minimize the...
21 CFR 640.120(a) - (a) The Director, Center for Biologics Evaluation and Research, may issue an exception or alterna...
21 CFR 640.120 - Alternative procedures.
21 CFR 660.31 - Eligibility of donor.
21 CFR 660.32 - Collection of source material.