Warning letter
Ohm Laboratories, Inc. [ARCHIVED]: warning letter of Dec 21, 2009
FDA warning letter 76304 · New York District Office
Key facts
| Reference number | 76304 |
|---|---|
| Company | Ohm Laboratories, Inc. [ARCHIVED] |
| Subject | CGMP for Finished Pharmaceuticals/Adulterated |
| Issue date | Dec 21, 2009 |
| Posted date | Dec 21, 2009 |
| Issuing office | New York District Office |
| Product type | Drugs |
| CFR sections cited | 211.160(b), 211.166(a), 314.81(b)(2)(ii), 211.68, 211.25, 314.81, 211.166, 211.192, 211.198, 211.68(a), 211.110(a) |
| Inspection city | Gloversville |
| Inspection ZIP | 12078 |
| Inspection start date | Jul 13, 2009 |
| Letter on fda.gov | web.archive.org |
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: