FDA Inspection
Catalent Belgium SACatalent Belgium SA – FDA Inspection, Jun 19, 2019
Record Details
This FDA Inspection record concerns Catalent Belgium SA, with an inspection on June 19, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 8808ef61-857f-4e6e-ad95-cd1aacefd7ff
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093395
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Catalent Belgium SA
13| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2024 | Not classified | Office of Inspections and Investigations | |
| April 7, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 19, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2019 | Not classified | Office of Inspections and Investigations |
Other documents for Catalent Belgium SA
- FDA Inspection 1273463 - 2024-07-12
- FDA Inspection 1246550 - 2023-04-07
- FDA Inspection 1177876 - 2022-08-19
- FDA Inspection 1136201 - 2020-01-22
- FDA Inspection 1082390 - 2019-02-15
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