FDA Inspection
F. Hoffmann - La Roche Ltd.F. Hoffmann - La Roche Ltd. – FDA Inspection, May 4, 2018
Record Details
This FDA Inspection record concerns F. Hoffmann - La Roche Ltd., with an inspection on May 4, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 28cab731-84a3-457d-8de0-0d1c60a8d55c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1051581
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 600.14(c)When to report
- 21 CFR 211.192Investigations of discrepancies, failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of F. Hoffmann - La Roche Ltd.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2024 | Not classified | Office of Inspections and Investigations | |
| August 5, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 21, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 8, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for F. Hoffmann - La Roche Ltd.
- FDA Inspection 1265000 - 2024-11-04
- FDA Inspection 1177103 - 2022-08-05
- FDA Inspection 990453 - 2016-09-13
- FDA Inspection 963013 - 2016-01-21
- FDA Inspection 878377 - 2014-04-08
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