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 [21 CFR 211.113(b)]. For example:
Passage 2Failure 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)].** Specifically, you have not validated the manufacturing processes for your products with respect to identity, strength, quality, and purity. For example, your validation for umbilical cord processing only included bioburden testing as a measurement of product attributes.
Passage 3Failure to establish and follow a written testing program designed to assess the stability characteristics of drug products and to use the results of such stability testing to determine appropriate storage conditions and expiration dates [21 CFR 211.166(a)].** Specifically, you assign a five-year expiration date to your products without supporting data regarding the stability characteristics of the products.***1
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 1271.10(a)(2)
- 21 CFR 1271.3(c)
- 21 CFR 1271.10(a)(1)
- 21 CFR 1271.3(f)(1)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.100(a)
- 21 CFR 211.166(a)
- 21 CFR 312