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. Your firm also failed to validate and establish the reliability of your component suppliers’ test analyses at appropriate intervals (21 CFR 211.84(d)(1)) and 211.84(d)(2).
Passage 2You failed to adequately test samples of your incoming components before using them to manufacture your homeopathic and OTC drug products. During the inspection, you informed the investigator that you reviewed certificates of analysis (COAs) for incoming materials, but did not perform identity testing, did not verify the supplier COA, and did not have a quarantine or approval process.
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 211.22
- 21 CFR 211.22(d)
- 21 CFR 211.100(a)
- 21 CFR 211.188(b)
- 21 CFR 211.160(b)
- 21 CFR 211.67(a)