Warning letter
Les Produits Chimiques B.G.R., Inc.: warning letter of Jul 24, 2018
FDA warning letter UCM615346 · Center for Drug Evaluation and Research
Key facts
| Reference number | UCM615346 |
|---|---|
| Company | Les Produits Chimiques B.G.R., Inc. |
| Subject | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
| Issue date | Jul 24, 2018 |
| Posted date | Jul 24, 2018 |
| Issuing office | Center for Drug Evaluation and Research |
| Product type | Drugs |
| CFR sections cited | 211.34 |
| Country | 3 |
| Inspection city | Pointe-Claire |
| Inspection start date | Sep 25, 2017 |
| Letter on fda.gov | fda.gov |
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: