Warning letter
Les Emballages Facoteck Inc: warning letter of Aug 21, 2018
FDA warning letter 547755 · Center for Drug Evaluation and Research
Key facts
| Reference number | 547755 |
|---|---|
| Company | Les Emballages Facoteck Inc |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Aug 21, 2018 |
| Posted date | Sep 18, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.137(a), 201.61, 201.66, 211.34, 211.22(d), 211.67(b), 211.100(a), 211.160(a), 201.66(d), 201.66(c) |
| Inspection city | Scotstown |
| Inspection start date | Nov 27, 2017 |
| Letter on fda.gov | fda.gov |
At a glance
- 10–99 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
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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: