FDA Inspection
Catalent Pharma Solutions LimitedCatalent Pharma Solutions Limited – FDA Inspection, Sep 12, 2014
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions Limited, with an inspection on September 12, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 12, 2014
- Product Type
- Drugs
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ID · 26587b6f-c963-4228-b6bf-85af1c37a1a4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 897773
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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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