FDA Inspection
Catalent Indiana, LLCCatalent Indiana, LLC – FDA Inspection, Nov 15, 2023
Record Details
This FDA Inspection record concerns Catalent Indiana, LLC, with an inspection on November 15, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · d2add1e6-726c-497d-9573-a93cfc3f443d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1224264
- FDA center
- Biologics
- Project area
- Vaccines and Allergenic Products
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Catalent Indiana, LLC
15| Date | Classification | Office | Project area |
|---|---|---|---|
| April 24, 2026 | Not classified | Detroit District Office | |
| July 14, 2025 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 12, 2023 | Not classified | Detroit District Office | |
| September 1, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 18, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Catalent Indiana, LLC
- FDA Inspection 1317904 - 2026-04-24
- FDA Inspection 1264264 - 2025-07-14
- FDA Inspection 1208718 - 2023-05-12
- FDA Inspection 1178819 - 2022-09-01
- FDA Inspection 1111350 - 2019-10-18
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