Warning letter
Concept Laboratories, Inc.: warning letter of Sep 1, 2008
FDA warning letter UCM1048155 · Chicago District Office
Key facts
| Reference number | UCM1048155 |
|---|---|
| Company | Concept Laboratories, Inc. |
| Subject | CGMP for Finished Pharmaceuticals/Deviations/Adulterated |
| Issue date | Sep 1, 2008 |
| Posted date | Sep 1, 2008 |
| Issuing office | Chicago District Office |
| Product type | Drugs |
| CFR sections cited | 201.66, 211.192, 201.10(c)(4), 201.66(b)(2), 347, 358, 211.67(a), 211.100(a), 211.100(b), 211.194(a)(6), 201.66(c)(8), 358.710(a)(3) and 4 more |
| Country | 3 |
| Inspection city | Chicago |
| Inspection ZIP | 60642-1522 |
| Inspection start date | Dec 12, 2007 |
| 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: