FDA Inspection
F. Hoffmann - La Roche Ltd.F. Hoffmann - La Roche Ltd. – FDA Inspection, Jul 25, 2013
Record Details
This FDA Inspection record concerns F. Hoffmann - La Roche Ltd., with an inspection on July 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- F. Hoffmann - La Roche Ltd.
- Inspection Date
- July 25, 2013
- Product Type
- Devices
View Company Profile
ID · c4f9a9c3-7587-4108-8024-1a618ea1c8f9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844683
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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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 | |
| August 5, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
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