Warning letter
Trilogy Laboratories, LLC: warning letter of Mar 5, 2020
FDA warning letter 595087 · Office of Pharmaceutical Quality Operations, Division II
Key facts
| Reference number | 595087 |
|---|---|
| Company | Trilogy Laboratories, LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Mar 5, 2020 |
| Posted date | Mar 31, 2020 |
| Issuing office | Office of Pharmaceutical Quality Operations, Division II |
| Product type | Drugs |
| CFR sections cited | 330.1, 201.61, 201.66, 201.128, 333, 201.66(b)(2), 211.84(d)(1), 211.100(a), 211.165(a) |
| Inspection city | Fort Myers |
| Inspection ZIP | 33913 |
| Inspection start date | Aug 22, 2019 |
| 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: