Warning letter
Laboratoire Atlas Inc. [ARCHIVED]: warning letter of Jun 25, 2009
FDA warning letter 53422 · Center for Drug Evaluation and Research
Key facts
| Reference number | 53422 |
|---|---|
| Company | Laboratoire Atlas Inc. [ARCHIVED] |
| Subject | Pharmaceutical Manufacturing Facility/CGMP |
| Issue date | Jun 25, 2009 |
| Posted date | Jun 25, 2009 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.113(b), 211.160(b), 211.180(e)(2), 211.67(a), 211.142(b), 200.50, 201.66, 211.63, 211.192, 310.502, 211.22(b), 211.25(b) |
| Inspection city | Anjou |
| Inspection start date | Sep 2, 2008 |
| 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: