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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2))
Passage 2You failed to perform adequate identity testing for each component lot including your active pharmaceutical ingredient (API), **(b)(4)**, used in the production of your over-the-counter (OTC) drug products.
Passage 3Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess. Your firm also failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.100(a) and 211.67(b)).
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 210
- 21 CFR 211.84(d)(1)
- 21 CFR 211.100(a)
- 21 CFR 211.22
- 21 CFR 211.192
- 21 CFR 211.188
- 21 CFR 211.166(a)
- 21 CFR 211.180(e)