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 conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).
Passage 2Your 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 (21 CFR 211.100(a)).
Passage 3Your firm failed to adequately validate your production and process controls. As such, you do not have assurance that you are capable of consistently manufacturing an OTC drug product with defined quality attributes.
Passage 4Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58).
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 211.58