Warning letter
Degasa S.A. De C.V.: warning letter of Apr 18, 2018
FDA warning letter 542521 · Center for Drug Evaluation and Research
Key facts
| Reference number | 542521 |
|---|---|
| Company | Degasa S.A. De C.V. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Apr 18, 2018 |
| Posted date | Apr 24, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.194(a), 211.165(b), 211.34, 201.66, 201.15, 201.61 |
| Inspection city | Jiutepec |
| Inspection start date | Sep 4, 2017 |
| 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: