Warning letter
Polimeros y Servicios S.A.: warning letter of Aug 22, 2019
FDA warning letter 586323 · Center for Drug Evaluation and Research
Key facts
| Reference number | 586323 |
|---|---|
| Company | Polimeros y Servicios S.A. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Unapproved/Misbranded |
| Issue date | Aug 22, 2019 |
| Posted date | Sep 3, 2019 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 201.61, 201.128, 211.34, 330.1, 211.67(b), 211.84(d)(1), 211.165(a), 310.545(a)(22)(iii), 211.137(a), 333.250(a), 333.350(a) |
| Inspection city | Tibas |
| Inspection start date | Feb 4, 2019 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 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: