Warning letter
OHM Pharma, Inc.: warning letter of Nov 19, 2019
FDA warning letter 586428 · Office of Pharmaceutical Quality
Key facts
| Reference number | 586428 |
|---|---|
| Company | OHM Pharma, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Nov 19, 2019 |
| Posted date | Dec 10, 2019 |
| Issuing office | Office of Pharmaceutical Quality |
| Product type | Drugs |
| CFR sections cited | 111.113(b)(2), 111.123(b)(2), 211.34, 101, 101.36, 111, 111.103, 111.210, 111.260, 101.7(f), 101.4(h), 111.15(b)(1) and 16 more |
| Inspection city | Mineral Wells |
| Inspection ZIP | 76067 |
| Inspection start date | May 14, 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: