FDA Inspection
Cilag AGCilag AG – FDA Inspection, Jul 16, 2019
Record Details
This FDA Inspection record concerns Cilag AG, with an inspection on July 16, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 63bceb9e-d60d-43bb-a4a4-9d7d2567769f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096373
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
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Other FDA inspections of Cilag AG
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2025 | Not classified | Office of Inspections and Investigations | |
| September 23, 2024 | Not classified | Office of Inspections and Investigations | |
| May 5, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 8, 2017 | Not classified | Office of Inspections and Investigations | |
| May 19, 2017 | Not classified | Office of Inspections and Investigations | Drug Quality Assurance |
Other documents for Cilag AG
- FDA Inspection 1279364 - 2025-06-24
- FDA Inspection 1257059 - 2024-09-23
- FDA Inspection 1208475 - 2023-05-05
- FDA Inspection 1046091 - 2017-12-08
- FDA Inspection 1014940 - 2017-05-19
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