Warning letter
Able Laboratories Inc.: warning letter of Apr 19, 2004
FDA warning letter UCM146349 · New Jersey District Office
Key facts
| Reference number | UCM146349 |
|---|---|
| Company | Able Laboratories Inc. |
| Subject | Postmarketing Adverse Drug Experience Reporting Requirements |
| Issue date | Apr 19, 2004 |
| Posted date | Apr 19, 2004 |
| Issuing office | New Jersey District Office |
| Product type | Drugs |
| CFR sections cited | 211, 310.305, 314.80, 314.80(c) |
| Country | 3 |
| Inspection city | S Plainfield |
| Inspection ZIP | 07080-4204 |
| Inspection start date | Jan 15, 2004 |
| 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: