Warning letter
Winder Laboratories, LLC: warning letter of Mar 26, 2019
FDA warning letter 567869 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 567869 |
|---|---|
| Company | Winder Laboratories, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 26, 2019 |
| Posted date | Apr 30, 2019 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.34, 211.67(b), 211.100(a), 211.194(a) |
| Inspection city | Winder |
| Inspection ZIP | 30680 |
| Inspection start date | Jul 9, 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: