Warning letter
Westlab Pharmacy, Inc. dba Westlab Pharmacy: warning letter of Jun 26, 2019
FDA warning letter 585571 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 585571 |
|---|---|
| Company | Westlab Pharmacy, Inc. dba Westlab Pharmacy |
| Subject | CGMP/Drug Products/Adulterated |
| Issue date | Jun 26, 2019 |
| Posted date | Jul 23, 2019 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 200.10(b), 211.80(a), 211.165(a), 210.1(b), 211.137(a) |
| Inspection city | Gainesville |
| Inspection ZIP | 32607 |
| Inspection start date | Aug 6, 2018 |
| 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: