Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1However, the methods you submitted did not include an appropriate identity test for ethanol, nor did the methods include testing for methanol, as required under 21 CFR 211.84. In addition, your test methods did not include appropriate assay testing for finished product as required per 21 CFR 211.165.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 211.84
- 21 CFR 211.165