Warning letter
PEL Associates Inc.: warning letter of Mar 22, 2000
FDA warning letter UCM068261 · New Jersey District Office
Key facts
| Reference number | UCM068261 |
|---|---|
| Company | PEL Associates Inc. |
| Subject | Good Manufacturing Practices Violation/Finished Pharmaceuticals |
| Issue date | Mar 22, 2000 |
| Posted date | Mar 22, 2000 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 211, 211.100(a), 211.84(e), 211.165(a), 211.192 |
| Country | 3 |
| Inspection city | Branchburg |
| Inspection ZIP | 08876-6032 |
| Inspection start date | Feb 8, 2000 |
| 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: