FDA Inspection
Zambon Switzerland Ltd.Zambon Switzerland Ltd. – FDA Inspection, Mar 30, 2016
Record Details
This FDA Inspection record concerns Zambon Switzerland Ltd., with an inspection on March 30, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Zambon Switzerland Ltd.
- Inspection Date
- March 30, 2016
- Product Type
- Drugs
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ID · d7a3afdd-64e9-4f27-89de-563e83a09d4b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965340
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(a)Approval and review of procedures
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Other FDA inspections of Zambon Switzerland Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2024 | Not classified | Office of Inspections and Investigations | |
| December 13, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 19, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 7, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Zambon Switzerland Ltd.
- FDA Inspection 1266438 - 2024-12-12
- FDA Inspection 1116041 - 2019-12-13
- FDA Inspection 1044858 - 2018-02-13
- FDA Inspection 874207 - 2013-12-19
- FDA Inspection 685280 - 2010-07-07
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