FDA Inspection
Catalent Pharma Solutions LLCCatalent Pharma Solutions LLC – FDA Inspection, Dec 15, 2022
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions LLC, with an inspection on December 15, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- December 15, 2022
- Product Type
- Drugs
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ID · 7112a2e8-ff38-4600-8d7e-03bec0917ecd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1195585
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.165(e)Test methods
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Other FDA inspections of Catalent Pharma Solutions LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2026 | Not classified | Atlanta District Office | Drug Quality Assurance |
| May 24, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 2, 2019 | Not classified | Atlanta District Office |
Other documents for Catalent Pharma Solutions LLC
- FDA Inspection 1303072 - 2026-05-22
- FDA Inspection 1229061 - 2024-05-24
- FDA Inspection 1131607 - 2020-09-28
- FDA Inspection 1116748 - 2019-12-20
- FDA Inspection 1102199 - 2019-08-02
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