Warning letter
Allay Pharmaceuticals, LLC: warning letter of Jan 27, 2021
FDA warning letter 609023 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 609023 |
|---|---|
| Company | Allay Pharmaceuticals, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jan 27, 2021 |
| Posted date | Feb 9, 2021 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.166(a), 211.22, 211.34, 211.192, 211.100(a), 600.3(h)(6) |
| Inspection city | Hialeah |
| Inspection ZIP | 33014 |
| Inspection start date | May 5, 2020 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: