Drug factory · FDA FEI 1053439
Cosette Pharmaceuticals NC Laboratories, LLC
1877 Kawai Road, Lincolnton, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 21, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2011: 5 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 21, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 30, 2017 | No problems found | Drug Quality Assurance | — |
| Jul 29, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 24, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 25, 2012 | No problems found | Drug Quality Assurance | — |
| Mar 4, 2011 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 21, 2023 inspection
- Incoming material area 21 CFR 211.42(c)(1)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components and drug product containers pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging. - Written Procedures Not Followed 21 CFR 211.80(a)
Written procedures are not followed for the storage and handling of components.
Registered with FDA for: analysis; label; manufacture; pack.