FDA Inspection
F. Hoffmann-La Roche AGF. Hoffmann-La Roche AG – FDA Inspection, Aug 28, 2009
Record Details
This FDA Inspection record concerns F. Hoffmann-La Roche AG, with an inspection on August 28, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- F. Hoffmann-La Roche AG
- Inspection Date
- August 28, 2009
- Product Type
- Drugs
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ID · 29798955-66be-43bd-b76d-cfeae2d6767a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 615375
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.56(b)Written sanitation procedures not followed
Showing 10 of 11 citations.
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Other FDA inspections of F. Hoffmann-La Roche AG
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 4, 2024 | Not classified | Office of Inspections and Investigations | |
| February 16, 2024 | Not classified | Office of Inspections and Investigations | |
| January 25, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| July 27, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 24, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for F. Hoffmann-La Roche AG
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- FDA Inspection 1228527 - 2024-01-25
- FDA Inspection 1180665 - 2022-07-27
- FDA Inspection 1055453 - 2018-04-24
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