Warning letter
Concept Laboratories, Inc.: warning letter of Feb 26, 2003
FDA warning letter UCM147308 · Chicago District Office
Key facts
| Reference number | UCM147308 |
|---|---|
| Company | Concept Laboratories, Inc. |
| Subject | CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated |
| Issue date | Feb 26, 2003 |
| Posted date | Feb 26, 2003 |
| Issuing office | Chicago District Office |
| Product type | Drugs |
| CFR sections cited | 211.67(b)(3), 211.188(b)(2), 211.186, 211.192, 211.165(f), 211.67(b) |
| Country | 3 |
| Inspection city | Chicago |
| Inspection ZIP | 60642-1522 |
| Inspection start date | Jan 7, 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: