Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes [21 CFR 211.113(b)].
Passage 2Failure 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,
Passage 3Your firm failed to conduct at least one test to verify the identity of each component of a drug product [21 CFR 211.84(d)(1)].** For example, your firm does not conduct identity tests when receiving lots of sterile **(b)(4)** sodium chloride, an ingredient used to manufacture the “tonicity solution” and glycerin contained in your Regener-Eyes® PRO and Regener-Eyes® LITE products.
Passage 4Failure 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, you had not validated your process for cleaning and disinfecting the Biological Safety Cabinets (BSCs) and supporting cleanrooms where your ophthalmic products were manufactured.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 1271.3(d)
- 21 CFR 1271.3(d)(3)
- 21 CFR 1271
- 21 CFR 200.50(a)(2)
- 21 CFR 207.1
- 21 CFR 207.77(a)
- 21 CFR 210
- 21 CFR 211.166(a)
- 21 CFR 211.113(b)
- 21 CFR 211.42(c)(10)(iv)
- 21 CFR 211.84(d)(1)
- 21 CFR 211.188(b)(3)
- 21 CFR 211.42(c)(10)(v)
- 21 CFR 211.180(a)
- 21 CFR 211.170(b)
- 21 CFR 211.94(b)
- 21 CFR 312