Warning letter
Prescript Pharmaceuticals, Inc.: warning letter of Dec 22, 2003
FDA warning letter UCM147887 · San Francisco District Office
Key facts
| Reference number | UCM147887 |
|---|---|
| Company | Prescript Pharmaceuticals, Inc. |
| Subject | CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated |
| Issue date | Dec 22, 2003 |
| Posted date | Dec 22, 2003 |
| Issuing office | San Francisco District Office |
| Product type | Drugs |
| CFR sections cited | 211.42, 211.137, 211.176, 211.42(c), 211.80(a), 211.170(b) |
| Country | 3 |
| Inspection city | Pleasanton |
| Inspection ZIP | 94566-6279 |
| Inspection start date | Jul 1, 2003 |
| Letter on fda.gov | web.archive.org |
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: