FDA Inspection 1156679 — Allay Pharmaceuticals, LLC
The FDA completed an inspection of Allay Pharmaceuticals, LLC on Nov 15, 2021 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
- Nov 15, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |