Warning letter
Walfer Corporation dba The Medicine Shoppe Pharmacy: warning letter of Sep 17, 2021
FDA warning letter 611017 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 611017 |
|---|---|
| Company | Walfer Corporation dba The Medicine Shoppe Pharmacy |
| Subject | Compounding Pharmacy/Adulterated Drug Products |
| Issue date | Sep 17, 2021 |
| Posted date | Oct 5, 2021 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 211.67(a), 201.115, 200.10(b), 211.56(a), 210.1(b) |
| Inspection city | Port Charlotte |
| Inspection ZIP | 33952 |
| Inspection start date | Mar 9, 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: