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 have an adequate system for monitoring environmental conditions in an aseptic processing area [21 CFR 211.42(c)(10)(iv)].** Your firm has not established an adequate system for environmental monitoring in the aseptic processing areas where your products are manufactured. For example:
Passage 3Failure to have an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions [21 CFR 211.42(c)(10)(v)].** For example, your firm has failed to validate the cleaning process for the ISO 7 clean room and BSCs used in the production of all your products purported to be sterile.
Passage 4Failure 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 assigned a two-year expiration date to your products without establishing a testing program to determine the stability characteristics.
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 1271.15
- 21 CFR 1271
- 21 CFR 1271.3(d)
- 21 CFR 1271.3(c)
- 21 CFR 1271.10(a)(2)
- 21 CFR 1271.10(a)(1)
- 21 CFR 1271.3(f)(1)
- 21 CFR 210
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.160(b)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.100(a)
- 21 CFR 211.166(a)
- 21 CFR 312