Drug factory · FDA FEI 1000122400
Catalent Pharma Solutions, LLC
1100 Enterprise Drive, Winchester, KY, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 22, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2008: 6 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jan 11, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 15, 2017 | No problems found | Drug Quality Assurance | — |
| May 4, 2017 | No problems found | Drug Quality Assurance | — |
| Jun 27, 2014 | No problems found | Drug Quality Assurance | — |
| Feb 5, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 14, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 19, 2012 | No problems found | Drug Quality Assurance | — |
| Apr 21, 2011 | No problems found | Drug Quality Assurance | — |
| Dec 9, 2008 | Problems found, fixed voluntarily | 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.
Apr 22, 2025 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Jan 11, 2023 inspection
- Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.
Registered with FDA for: analysis; label; manufacture; pack.