FDA Inspection
Catalent Pharma Solutions LLCCatalent Pharma Solutions LLC – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions LLC, with an inspection on May 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 00b49545-c791-4540-9e3c-295621fee7af
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014725
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.42(c)(8)Released Drug Products Area
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| December 15, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
Other documents for Catalent Pharma Solutions LLC
- FDA Inspection 1303072 - 2026-05-22
- FDA Inspection 1229061 - 2024-05-24
- FDA Inspection 1195585 - 2022-12-15
- FDA Inspection 1131607 - 2020-09-28
- FDA Inspection 1116748 - 2019-12-20
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