FDA Inspection 1038062 — Allay Pharmaceuticals, LLC
The FDA completed an inspection of Allay Pharmaceuticals, LLC on Jan 17, 2018 in Hialeah, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 17, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1846 | 21 CFR 211.84(d)(3) | Establish reliability of supplier's C of A |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |