Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1FDA laboratory testing of a batch of this product detained at the border found that the drug product contained an average of only 58% ethanol volume/volume.
Passage 2the subpotency demonstrates that the quality assurance within your facility is not functioning in accordance with Current Good Manufacturing Practice (CGMP) requirements.
Passage 3The method you submitted uses a **(b)(4)** that is unsuitable for the testing of finished hand sanitizers that contain materials other than ethanol and water in their **(b)(4)**.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 211.160(b)