FDA Inspection
Catalent Pharma Solutions LLCCatalent Pharma Solutions LLC – FDA Inspection, Mar 4, 2019
Record Details
This FDA Inspection record concerns Catalent Pharma Solutions LLC, with an inspection on March 4, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b673401d-8dad-424f-aa50-39dab03b8722
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1081169
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Written record of investigation incomplete
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
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Other FDA inspections of Catalent Pharma Solutions LLC
12| Date | Classification | Office | Project area |
|---|---|---|---|
| May 22, 2026 | Not classified | Atlanta District Office | Drug Quality Assurance |
| May 24, 2024 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 15, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 28, 2020 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Catalent Pharma Solutions LLC
- FDA Inspection 1303072 - 2026-05-22
- FDA Inspection 1229061 - 2024-05-24
- FDA Inspection 1195585 - 2022-12-15
- FDA Inspection 1131607 - 2020-09-28
- FDA Inspection 1116748 - 2019-12-20
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