FDA Inspection
Catalent Pharma Solutions, LLCCatalent Pharma Solutions, LLC – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions, LLC, with an inspection on December 21, 2018, issued by the Cincinnati District Office, covering human drugs.
- People
- Andrew J. Barrowcliff
- Chiaochun J. Wang (Issuing Officer)
- Wayne D. Mcgrath
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ID · 03172b11-9f7e-47a2-9a2c-b2baa0126649
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075188
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Catalent Pharma Solutions, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2025 | VAI | Cincinnati District Office | Drug Quality Assurance |
| January 11, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 5, 2018 | Not classified | Cincinnati District Office | |
| November 15, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Catalent Pharma Solutions, LLC
- FDA Inspection 1264863 - 2025-04-22
- FDA Inspection 1195321 - 2023-01-11
- FDA Inspection 1045136 - 2018-02-05
- FDA Inspection 1038136 - 2017-11-15
- FDA Inspection 1012414 - 2017-05-04
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