FDA Inspection
F. Hoffmann - La Roche Ltd.F. Hoffmann - La Roche Ltd. – FDA Inspection, Aug 5, 2022
Record Details
This FDA Inspection record concerns F. Hoffmann - La Roche Ltd., with an inspection on August 5, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- F. Hoffmann - La Roche Ltd.
- Inspection Date
- August 5, 2022
- Product Type
- Drugs
View Company Profile
ID · 87f8c726-9f6d-40d2-8dab-dad1a856c5f4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1177103
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.192Written record of investigation incomplete
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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 | |
| May 4, 2018 | 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 1051581 - 2018-05-04
- FDA Inspection 990453 - 2016-09-13
- FDA Inspection 963013 - 2016-01-21
- FDA Inspection 878377 - 2014-04-08
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