Warning letter
Pharmaceutical Formulations, Inc.: warning letter of May 5, 2004
FDA warning letter UCM146379 · New Jersey District Office
Key facts
| Reference number | UCM146379 |
|---|---|
| Company | Pharmaceutical Formulations, Inc. |
| Subject | CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated |
| Issue date | May 5, 2004 |
| Posted date | May 5, 2004 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 211, 211.22, 211.188, 211.22(c), 211.25(a), 211.67(a), 211.67(b), 211.110(d), 211.130(e), 211.160(b)(3), 211.160(b)(4), 211.186(b)(9) and 3 more |
| Country | 3 |
| Inspection city | Edison |
| Inspection ZIP | 08817-2415 |
| Inspection start date | Jan 12, 2004 |
| 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: