FDA Inspection
Catalent Pharma Solutions LimitedCatalent Pharma Solutions Limited – FDA Inspection, Nov 18, 2011
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions Limited, with an inspection on November 18, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 18, 2011
- Product Type
- Drugs
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ID · 5aa7127a-96af-49b8-bf18-ca96803af9ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 759277
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Catalent Pharma Solutions Limited
9| Date | Classification | Office | Project area |
|---|---|---|---|
| October 10, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 15, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 20, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 23, 2018 | Not classified | Office of Inspections and Investigations | |
| July 26, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
Other documents for Catalent Pharma Solutions Limited
- FDA Inspection 1267053 - 2024-10-10
- FDA Inspection 1261182 - 2023-06-15
- FDA Inspection 1141164 - 2020-02-20
- FDA Inspection 1065786 - 2018-08-23
- FDA Inspection 1064287 - 2018-07-26
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