Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes, as required by 21 CFR 211.113(b).** For example, you failed to adequately validate (i.e., by performing media fill simulations) the aseptic process used to manufacture your Purified Fluid Allograft product. Your product purports to be sterile and is expected to be sterile.
Passage 2Failure to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess, as required by 21 CFR 211.100(a).** Specifically,
Passage 3Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates, as required by 21 CFR 211.166(a).** Specifically, you assigned a **(b)(4)** expiration date to your products without supporting data.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271.10(a)
- 21 CFR 1271
- 21 CFR 1271.15
- 21 CFR 1271.3(d)
- 21 CFR 1271.3(c)
- 21 CFR 1271.3
- 21 CFR 1271.20
- 21 CFR 1271.3(d)(3)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.100(a)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.192
- 21 CFR 211.166(a)
- 21 CFR 312