Warning letter
Apothecus Pharmaceutical Corp.: warning letter of Nov 8, 2019
FDA warning letter 585666 · Division of Pharmaceutical Quality Operations I
Key facts
| Reference number | 585666 |
|---|---|
| Company | Apothecus Pharmaceutical Corp. |
| Subject | CGMP/Drug Products/Adulterated |
| Issue date | Nov 8, 2019 |
| Posted date | Nov 19, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations I |
| Product type | Drugs |
| CFR sections cited | 211.22, 211.192, 4, 211.68(b) |
| Inspection city | Hicksville |
| Inspection ZIP | 11801-5071 |
| Inspection start date | Apr 15, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- 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: