FDA Inspection
Catalent Pharma Solutions, LLCCatalent Pharma Solutions, LLC – FDA Inspection, Feb 22, 2019
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions, LLC, with an inspection on February 22, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Ileana Barreto-Pettit (Issuing Officer)
- Jessica P. Mcalister (FDA Associated Person)
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ID · f65ec9d4-80a0-4c7e-8873-7b8eef0bdf8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1080109
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.100(b)SOPs not followed / documented
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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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