Warning letter
American Specialty Pharmacy, Inc. dba ASP Cares: warning letter of Apr 5, 2021
FDA warning letter 604003 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 604003 |
|---|---|
| Company | American Specialty Pharmacy, Inc. dba ASP Cares |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Apr 5, 2021 |
| Posted date | Apr 27, 2021 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 211.165(a), 210.1(b), 211.100(a), 201.115, 211.192, 211.198, 200.10(b) |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
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: