Warning Letters

Review Warning Letters by infraction

Regulations

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

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

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

21 CFR 1271.65(b) - (b) Limited uses of HCT/P from ineligible donor.

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

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

21 CFR 1271.75 - How do I screen a donor?

21 CFR 1271.75(a) - (a) All donors. Except as provided under § 1271.90, if you are the establishment that performs d...

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

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

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

21 CFR 1271.80 - What are the general requirements for donor testing?

21 CFR 1271.80(d) - (d) Ineligible donors. You must determine the following donors to be ineligible:

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 1271.60(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 1271.85(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(a) - (a) All donors. To adequately and appropriately reduce the risk of transmission of relevant comm...

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

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

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

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

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

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

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

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

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

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

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

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

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