Warning letter
GenPak Solutions LLC: warning letter of Jul 12, 2016
FDA warning letter 480257 · Cincinnati District Office
Key facts
| Reference number | 480257 |
|---|---|
| Company | GenPak Solutions LLC |
| Subject | CGMP/Finished Pharmaceuticals/Adulterated/Misbranded |
| Issue date | Jul 12, 2016 |
| Posted date | Jul 12, 2016 |
| Issuing office | Cincinnati District Office |
| Product type | Drugs |
| CFR sections cited | 211.22(a), 211.67(a), 211.100(a), 201.115, 211.166, 207.21(b) |
| Inspection city | Hilliard |
| Inspection ZIP | 43026 |
| Inspection start date | Aug 3, 2015 |
| Letter on fda.gov | web.archive.org |
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: