FDA Inspection
Catalent Pharma Solutions, LLCCatalent Pharma Solutions, LLC – FDA Inspection, Jul 21, 2023
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions, LLC, with an inspection on July 21, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Jose Perez-Soto (Issuing Officer)
- Lourdes Andujar
- Moraima J. Ramos-Valle (Investigator)
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ID · 90d4bb7b-c5b9-412b-9f5a-2300c5e0499b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1210540
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
16- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(b)(2)Specifications-component purity, strength, composition
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(b)(3)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.27(d)Equipment - maintain, clean, sanitize
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.255(b)Batch record - complete
- 21 CFR 111.205(a)Master manufacturing record - unique formulation
- 21 CFR 111.255(b)Batch record - complete
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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 |
| August 28, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 22, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1101180 - 2019-08-28
- FDA Inspection 1080109 - 2019-02-22
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