FDA Inspection
Catalent Indiana, LLCCatalent Indiana, LLC – FDA Inspection, May 19, 2017
Record Details
This FDA Inspection record concerns Catalent Indiana, LLC, with an inspection on May 19, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Emilie Kahn (Issuing Officer)
- Jeffrey D. Meng (FDA Associated Person)
- Sargum C. Morgan
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ID · 8bcaeb7f-53f7-4eae-8c26-a1ffe037141a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030478
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
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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 |
| November 15, 2023 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 12, 2023 | Not classified | Detroit District Office | |
| September 1, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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