FDA Inspection
Catalent Pharma Solutions LLCCatalent Pharma Solutions LLC – FDA Inspection, Sep 28, 2020
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions LLC, with an inspection on September 28, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 28, 2020
- Product Type
- Drugs
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ID · 97ae5f82-ff4f-4676-b3ee-7472c0837575
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1131607
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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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 |
| 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 1195585 - 2022-12-15
- FDA Inspection 1116748 - 2019-12-20
- FDA Inspection 1102199 - 2019-08-02
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