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, your firm has not validated the aseptic processes used to manufacture your umbilical cord derived products. Your umbilical cord derived products purport to be sterile and are expected to be sterile.
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 that they are purported or represented to possess, as required by 21 CFR 211.100(a).** For example, your firm has not validated the manufacturing processes for your umbilical cord derived products with respect to identity, strength, quality, and purity.
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).** For example, your firm assigns a 24-month expiration date to your products without supporting stability testing data.
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 1271.3(c)
- 21 CFR 1271.10(a)(4)
- 21 CFR 1271.6
- 21 CFR 1271.20
- 21 CFR 1271.75(a)(1)(iv)
- 21 CFR 210.3(b)(12)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.100(a)
- 21 CFR 211.160(b)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.166(a)
- 21 CFR 211.22(d)
- 21 CFR 211.22(a)
- 21 CFR 211.198(a)