Citations within the context of their regulations

Review the enforcement history for every citation given out with the Human Cellular Tissue sector.

21 CFR 1271.75(c) - (c) Donors of reproductive cells or tissue. In addition to the relevant communicable disease age...

21 CFR 1271.75(e) - (e) Abbreviated procedure for repeat donors. If you have performed a complete donor screening pr...

21 CFR 1271.75(d) - (d) Ineligible donors. You must determine ineligible a donor who is identified as having either ...

21 CFR 1271.75(b) - (b) Donors of viable, leukocyte-rich cells or tissue. In addition to the relevant communicable d...

21 CFR 1271.75(a)(1) - (1) Risk factors for, and clinical evidence of, relevant communicable disease agents and diseases...

21 CFR 1271.75(a)(2) - (2) Communicable disease risks associated with xenotransplantation.

21 CFR 1271.47(e) - (e) Standard procedures. You may adopt current standard procedures, such as those in a technical...

21 CFR 1271.47(c) - (c) Availability. Procedures must be readily available to the personnel in the area where the op...

21 CFR 1271.47(d) - (d) Departures from procedures. You must record and justify any departure from a procedure relev...

21 CFR 1271.47(b) - (b) Review and approval. Before implementation, a responsible person must review and approve all...

21 CFR 1271.47(a) - (a) General. You must establish and maintain procedures for all steps that you perform in testin...

21 CFR 1271.50(a) - (a) Determination based on screening and testing. If you are the establishment responsible for m...

21 CFR 1271.50(b)(1) - (1) Donor screening in accordance with § 1271.75 indicates that the donor:

21 CFR 1271.50(b)(2) - (2) The results of donor testing for relevant communicable disease agents in accordance with §§ 1...

21 CFR 1271.60(b) - (b) Identification of HCT/Ps in quarantine. You must clearly identify as quarantined an HCT/P th...

21 CFR 1271.60(a) - (a) Quarantine. You must keep an HCT/P in quarantine, as defined in § 1271.3(q), until completio...

21 CFR 1271.60(c) - (c) Shipping of HCT/Ps in quarantine

21 CFR 1271.60(c)(2) - (2) Stating that the donor-eligibility determination has not been completed; and

21 CFR 1271.60(c)(3) - (3) Stating that the product must not be implanted, transplanted, infused, or transferred until c...

21 CFR 1271.85(a) - (a) All donors. To adequately and appropriately reduce the risk of transmission of relevant comm...

21 CFR 1271.85(d) - (d) Retesting anonymous semen donors. Except as provided under § 1271.90 and except for directed...

21 CFR 1271.85(c) - (c) Donors of reproductive cells or tissue. In addition to the communicable disease agents for w...

21 CFR 1271.85(b)(1) - (1) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue to adequate...

21 CFR 1271.85(b)(2) - (2) You must test a specimen from the donor of viable, leukocyte-rich cells or tissue for evidenc...

21 CFR 1271.55(c) - (c) Deletion of personal information. The accompanying records required by this section must not...

21 CFR 1271.55(d)(2) - (2) All records must be accurate, indelible, and legible. Information on the identity and relevan...

21 CFR 1271.55(d)(3) - (3) You must retain required records and make them available for authorized inspection by or upon...

21 CFR 1271.55(d)(4) - (4) You must retain the records pertaining to a particular HCT/P at least 10 years after the date...

21 CFR 1271.55(d)(1) - (1) You must maintain documentation of:

21 CFR 1271.55(d)(1)(i) - (i) Results and interpretation of all testing for relevant communicable disease agents in complia...

21 CFR 1271.55(d)(1)(ii) - (ii) Results and interpretation of all donor screening for communicable diseases in compliance wi...

21 CFR 1271.55(d)(1)(iii) - (iii) The donor-eligibility determination, including the name of the responsible person who made ...

21 CFR 1271.55(a)(1) - (1) A distinct identification code affixed to the HCT/P container, e.g., alphanumeric, that relat...

21 CFR 1271.55(a)(2) - (2) A statement whether, based on the results of screening and testing, the donor has been determ...

21 CFR 1271.55(a)(3) - (3) A summary of the records used to make the donor-eligibility determination.

21 CFR 1271.55(b)(1) - (1) A statement that the communicable disease testing was performed by a laboratory:

21 CFR 1271.55(b)(2) - (2) A listing and interpretation of the results of all communicable disease tests performed;

21 CFR 1271.55(b)(3) - (3) The name and address of the establishment that made the donor-eligibility determination; and

21 CFR 1271.55(b)(4) - (4) In the case of an HCT/P from a donor who is ineligible based on screening and released under ...

21 CFR 1271.65(c) - (c) Nonclinical use. You may make available for nonclinical purposes an HCT/P from a donor who h...

21 CFR 1271.65(a) - (a) Storage. If you are the establishment that stores the HCT/P, you must store or identify HCT/...

21 CFR 1271.65(b)(2) - (2) You must prominently label an HCT/P made available for use under the provisions of paragraph ...

21 CFR 1271.65(b)(3) - (3) If you are the establishment that manufactured an HCT/P used under the provisions of paragrap...

21 CFR 1271.90(c) - (c) Required labeling

21 CFR 1271.90(c)(1) - (1) “FOR AUTOLOGOUS USE ONLY,” if it is stored for autologous use.

21 CFR 1271.80(b) - (b) Timing of specimen collection. You must collect the donor specimen for testing at the time o...

21 CFR 1271.80(a) - (a) Testing for relevant communicable diseases is required. To adequately and appropriately redu...

21 CFR 1271.80(c) - (c) Tests. You must test using appropriate FDA-licensed, approved, or cleared donor screening te...

21 CFR 1271.80(d)(1) - (1) A donor whose specimen tests reactive on a screening test for a communicable disease agent in...

21 CFR 1271.150(c)(2) - (2) If you are the establishment that determines that an HCT/P meets all release criteria and mak...

21 CFR 1271.150(c)(1)(iii) - (iii) Before entering into a contract, agreement, or other arrangement with another establishment...

21 CFR 1271.210(a) - (a) Verification. You must not use supplies and reagents until they have been verified to meet s...

21 CFR 1271.210(b) - (b) Reagents. Reagents used in processing and preservation of HCT/Ps must be sterile, where appr...

21 CFR 1271.210(c) - (c) In-house reagents. You must validate and/or verify the processes used for production of in-h...

21 CFR 1271.210(d)(1) - (1) Records of the receipt of each supply or reagent, including the type, quantity, manufacturer,...

21 CFR 1271.210(d)(2) - (2) Records of the verification of each supply or reagent, including test results or, in the case...

21 CFR 1271.210(d)(3) - (3) Records of the lot of supply or reagent used in the manufacture of each HCT/P.

21 CFR 1271.260(d) - (d) Corrective action. You must take and document corrective action whenever proper storage cond...

21 CFR 1271.260(b) - (b) Temperature. You must store HCT/Ps at an appropriate temperature.

21 CFR 1271.260(c) - (c) Expiration date. Where appropriate, you must assign an expiration date to each HCT/P based o...

21 CFR 1271.260(e) - (e) Acceptable temperature limits. You must establish acceptable temperature limits for storage ...

21 CFR 1271.260(a) - (a) Control of storage areas. You must control your storage areas and stock rooms to prevent:

21 CFR 1271.190(c) - (c) Operations. You must divide a facility used in the manufacture of HCT/Ps into separate or de...

21 CFR 1271.190(a) - (a) General. Any facility used in the manufacture of HCT/Ps must be of suitable size, constructi...

21 CFR 1271.190(d)(1) - (1) You must establish and maintain procedures for facility cleaning and sanitation for the purpo...

21 CFR 1271.190(d)(2) - (2) You must document, and maintain records of, all cleaning and sanitation activities performed ...

21 CFR 1271.190(b)(1) - (1) You must maintain any facility used in the manufacture of HCT/Ps in a clean, sanitary, and or...

21 CFR 1271.190(b)(2) - (2) You must dispose of sewage, trash, and other refuse in a timely, safe, and sanitary manner.

21 CFR 1271.225 - Process changes.

21 CFR 1271.230(c) - (c) Changes. When changes to a validated process subject to paragraph (a) of this section occur,...

21 CFR 1271.230(b) - (b) Written representation. Any written representation that your processing methods reduce the r...

21 CFR 1271.230(a) - (a) General. Where the results of processing described in § 1271.220 cannot be fully verified by...

21 CFR 1271.270(e) - (e) Contracts and agreements. You must maintain the name and address and a list of the responsib...

21 CFR 1271.270(b) - (b) Records management system. You must establish and maintain a records management system relat...

21 CFR 1271.270(d) - (d) Length of retention. You must retain all records for 10 years after their creation, unless s...

21 CFR 1271.270(a) - (a) General. You must maintain records concurrently with the performance of each step required i...

21 CFR 1271.270(c) - (c) Methods of retention. You may maintain records required under this subpart electronically, a...

21 CFR 1271.220(a) - (a) General. If you are an establishment that processes HCT/Ps, you must process each HCT/P in a...

21 CFR 1271.220(c) - (c) In-process control and testing. You must ensure that specified requirements, consistent with...

21 CFR 1271.320(b) - (b) Complaint file. You must maintain a record of complaints that you receive in a file designat...

21 CFR 1271.320(c) - (c) Review and evaluation of complaints. You must review and evaluate each complaint relating to...

21 CFR 1271.320(a) - (a) Procedures. You must establish and maintain procedures for the review, evaluation, and docum...

21 CFR 1271.180(c) - (c) Availability. These procedures must be readily available to the personnel in the area where ...

21 CFR 1271.180(b) - (b) Review and approval. Before implementation, a responsible person must review and approve the...

21 CFR 1271.180(a) - (a) General. You must establish and maintain procedures appropriate to meet core CGTP requiremen...

21 CFR 1271.180(d) - (d) Standard procedures. If you adopt current standard procedures from another organization, you...

21 CFR 1271.160(a) - (a) General. If you are an establishment that performs any step in the manufacture of HCT/Ps, yo...

21 CFR 1271.160(d) - (d) Computers. You must validate the performance of computer software for the intended use, and ...

21 CFR 1271.160(c) - (c) Audits. You must periodically perform for management review a quality audit, as defined in §...

21 CFR 1271.160(b)(1) - (1) Establishing and maintaining appropriate procedures relating to core CGTP requirements, and e...

21 CFR 1271.160(b)(3) - (3) Ensuring that appropriate corrective actions relating to core CGTP requirements, including re...

21 CFR 1271.160(b)(4) - (4) Ensuring the proper training and education of personnel involved in activities related to cor...

21 CFR 1271.160(b)(5) - (5) Establishing and maintaining appropriate monitoring systems as necessary to comply with the r...

21 CFR 1271.160(b)(6) - (6) Investigating and documenting HCT/P deviations and trends of HCT/P deviations relating to cor...

21 CFR 1271.160(b)(2) - (2) Ensuring that procedures exist for receiving, investigating, evaluating, and documenting info...

21 CFR 1271.160(b)(2)(ii) - (ii) Other establishments that are known to have performed manufacturing steps with respect to th...

21 CFR 1271.160(b)(2)(iii) - (iii) Relating to consignees, in the case of such information received after the HCT/P is made av...

21 CFR 1271.170(c) - (c) Training. You must train all personnel, and retrain as necessary, to perform their assigned ...

21 CFR 1271.170(b) - (b) Competent performance of functions. You must have personnel with the necessary education, ex...

21 CFR 1271.170(a) - (a) General. You must have personnel sufficient to ensure compliance with the requirements of th...

21 CFR 1271.265(a) - (a) Receipt. You must evaluate each incoming HCT/P for the presence and significance of microorg...

21 CFR 1271.265(e) - (e) Procedures. You must establish and maintain procedures, including release criteria, for the ...

21 CFR 1271.265(b) - (b) Predistribution shipment. If you ship an HCT/P within your establishment or between establis...

21 CFR 1271.265(d) - (d) Packaging and shipping. Packaging and shipping containers must be designed and constructed t...

21 CFR 1271.265(f) - (f) Return to inventory. You must establish and maintain procedures to determine if an HCT/P tha...

21 CFR 1271.265(c)(1) - (1) Before making an HCT/P available for distribution, you must review manufacturing and tracking...

21 CFR 1271.265(c)(2) - (2) You must not make available for distribution an HCT/P that is in quarantine, is contaminated,...

21 CFR 1271.265(c)(3) - (3) You must not make available for distribution any HCT/P manufactured under a departure from a ...

21 CFR 1271.290(b) - (b) System of HCT/P tracking.

21 CFR 1271.290(e) - (e) Tracking from donor to consignee or final disposition. As part of your tracking system, you ...

21 CFR 1271.290(d) - (d) Tracking from consignee to donor. As part of your tracking system, you must establish and ma...

21 CFR 1271.290(a) - (a) General. If you perform any step in the manufacture of an HCT/P in which you handle the HCT/...

21 CFR 1271.290(c) - (c) Distinct identification code. As part of your tracking system, you must ensure: That each HC...

21 CFR 1271.290(f) - (f) Consignees. At or before the time of distribution of an HCT/P to a consignee, you must infor...

21 CFR 1271.195(b) - (b) Inspections. You must inspect each environmental control system periodically to verify that ...

21 CFR 1271.195(c) - (c) Environmental monitoring. You must monitor environmental conditions where environmental cond...

21 CFR 1271.195(d) - (d) Records. You must document, and maintain records of, environmental control and monitoring ac...

21 CFR 1271.195(a) - (a) Environmental control

21 CFR 1271.195(a)(1) - (1) Temperature and humidity controls;

21 CFR 1271.195(a)(2) - (2) Ventilation and air filtration;

21 CFR 1271.195(a)(3) - (3) Cleaning and disinfecting of rooms and equipment to ensure aseptic processing operations; and

21 CFR 1271.250(c) - (c) Labeling requirements. Procedures must ensure that each HCT/P is labeled in accordance with ...

21 CFR 1271.250(b) - (b) Verification. Procedures must include verification of label accuracy, legibility, and integr...

21 CFR 1271.250(a) - (a) General. You must establish and maintain procedures to control the labeling of HCT/Ps. You m...

21 CFR 1271.200(c) - (c) Calibration of equipment. Where appropriate, you must routinely calibrate according to estab...

21 CFR 1271.200(b) - (b) Procedures and schedules. You must establish and maintain procedures for cleaning, sanitizin...

21 CFR 1271.200(a) - (a) General. To prevent the introduction, transmission, or spread of communicable diseases, equi...

21 CFR 1271.200(e) - (e) Records. You must document and maintain records of all equipment maintenance, cleaning, sani...

21 CFR 1271.200(d) - (d) Inspections. You must routinely inspect equipment for cleanliness, sanitation, and calibrati...

21 CFR 1271.350(a)(1) - (1) You must investigate any adverse reaction involving a communicable disease related to an HCT/...

21 CFR 1271.350(a)(2) - (2) You must submit each report on a Form FDA-3500A to the address in paragraph (a)(5) of this se...

21 CFR 1271.350(b)(1) - (1) You must investigate all HCT/P deviations related to a distributed HCT/P for which you perfor...

21 CFR 1271.350(b)(2) - (2) You must report any such HCT/P deviation relating to the core CGTP requirements, if the HCT/P...

21 CFR 1271.370(a) - (a) You must label each HCT/P made available for distribution clearly and accurately.

21 CFR 1271.370(b)(1) - (1) Distinct identification code affixed to the HCT/P container, and assigned in accordance with ...

21 CFR 1271.370(b)(3) - (3) Expiration date, if any; and

21 CFR 1271.370(b)(4) - (4) Warnings required under § 1271.60(d)(2), § 1271.65(b)(2), or § 1271.90(c), if applicable and ...