FDA Inspection
Catalent Pharma Solutions LimitedCatalent Pharma Solutions Limited – FDA Inspection, Apr 20, 2018
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions Limited, with an inspection on April 20, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 9a66178c-e371-4567-b385-4a256196a668
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1048918
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.67(b)Written procedures not established/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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