Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to collect a donor specimen for testing for relevant communicable diseases at the time of recovery of cells or tissue from the donor or up to seven days before or after recovery [21 CFR 1271.80(b)]**. For example, HCT/Ps were recovered from donor **(b)(6), (b)(7)(C)** on **(b)(6), (b)(7)(C)**, however a donor specimen for testing was collected from the donor on **(b)(6), (b)(7)(C)**, which is not within the required timeframe for collection of a specimen for testing.
Passage 2Failure to screen a donor of cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases [21 CFR 1271.75(a)(1)]**. For example:
Passage 3Failure to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess [21 CFR 211.100(a)]**. For example, your firm has not validated the manufacturing process for the adipose tissue product, Ayama™, with respect to identity, strength, quality and purity.
Passage 4Failure to have an adequate system for monitoring environmental conditions in an aseptic processing area necessary to prevent contamination or mixups [21 CFR 211.42(c)(10)(iv)]**. For example,
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271
- 21 CFR 1271.10(a)
- 21 CFR 1271.15
- 21 CFR 1271.3(d)
- 21 CFR 1271.10(a)(1)
- 21 CFR 1271.3(f)(1)
- 21 CFR 1271.10(a)(2)
- 21 CFR 1271.3(c)
- 21 CFR 1271.85(a)
- 21 CFR 1271.3(r)
- 21 CFR 1271.80(b)
- 21 CFR 1271.80(c)
- 21 CFR 1271.75(a)(1)
- 21 CFR 1271.60(b)
- 21 CFR 1271.265(b)
- 21 CFR 1271.265(c)
- 21 CFR 210
- 21 CFR 211.100(a)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 312