FDA Inspection
Catalent Pharma Solutions, LLCCatalent Pharma Solutions, LLC – FDA Inspection, Jun 14, 2018
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions, LLC, with an inspection on June 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b2f1443c-74b0-4599-94e2-3f0c3724916b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056856
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Catalent Pharma Solutions, LLC
11| Date | Classification | Office | Project area |
|---|---|---|---|
| January 30, 2026 | Not classified | Florida District Office | |
| May 30, 2024 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 25, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 21, 2023 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| August 28, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Catalent Pharma Solutions, LLC
- FDA Inspection 1282788 - 2026-01-30
- FDA Inspection 1229815 - 2024-05-30
- FDA Inspection 1229344 - 2024-01-25
- FDA Inspection 1210540 - 2023-07-21
- FDA Inspection 1101180 - 2019-08-28
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