Warning letter
ChemRite CoPac, Inc.: warning letter of Jun 29, 2017
FDA warning letter 515029 · Detroit District Office
Key facts
| Reference number | 515029 |
|---|---|
| Company | ChemRite CoPac, Inc. |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated |
| Issue date | Jun 29, 2017 |
| Posted date | Jun 29, 2017 |
| Issuing office | Detroit District Office |
| Product type | Drugs |
| CFR sections cited | 210, 211.22(a), 211.42(c), 211.165(b) |
| Inspection city | Lannon |
| Inspection ZIP | 53046 |
| Inspection start date | Jun 9, 2016 |
| 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: