FDA Inspection
Gufic Biosciences LimitedGufic Biosciences Limited – FDA Inspection, Feb 6, 2015
Record Details
This FDA Inspection record concerns Gufic Biosciences Limited, with an inspection on February 6, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Gufic Biosciences Limited
- Inspection Date
- February 6, 2015
- Product Type
- Drugs
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ID · 65227fa3-7a34-4e7c-918c-2cbadfae7a8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 916730
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.182Written records kept in individual logs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Gufic Biosciences Limited
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Gufic Biosciences Limited
- FDA Inspection 709671 - 2010-08-28
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