FDA Inspection
F. Hoffmann - La Roche Ltd.F. Hoffmann - La Roche Ltd. – FDA Inspection, Sep 13, 2016
Record Details
This FDA Inspection record concerns F. Hoffmann - La Roche Ltd., with an inspection on September 13, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- F. Hoffmann - La Roche Ltd.
- Inspection Date
- September 13, 2016
- Product Type
- Drugs
View Company Profile
ID · 7a26357e-727b-4409-a5e4-f45e891db982
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 990453
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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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 |
| 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 1051581 - 2018-05-04
- FDA Inspection 963013 - 2016-01-21
- FDA Inspection 878377 - 2014-04-08
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