Warning letter
Frenda Corporation: warning letter of Feb 15, 2023
FDA warning letter 642267 · Division of Pharmaceutical Quality Operations II
Key facts
| Reference number | 642267 |
|---|---|
| Company | Frenda Corporation |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Feb 15, 2023 |
| Posted date | Mar 14, 2023 |
| Issuing office | Division of Pharmaceutical Quality Operations II |
| Product type | Drugs |
| CFR sections cited | 211.192, 211.165(a), 211.100(a), 211.188, 211.84(d)(1), 211.67(a), 211.42(c), 211.22(a), 211.34, 211.22, 211.165(b), 211.166(a) and 1 more |
| Inspection city | Trujillo Alto |
| Inspection ZIP | 00976 |
| Inspection start date | Jul 26, 2022 |
| 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: