FDA Inspection
Guna S.p.A.Guna S.p.A. – FDA Inspection, May 16, 2014
Record Details
This FDA Inspection record concerns Guna S.p.A., with an inspection on May 16, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Guna S.p.A.
- Inspection Date
- May 16, 2014
- Product Type
- Drugs
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ID · 7a2a2240-61a8-4b7d-9971-e6b6afe78596
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 880327
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.122(g)Failure to include one of special control procedures
- 21 CFR 211.170(b)Annual visual exams of drug products
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Other FDA inspections of Guna S.p.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 2, 2016 | Not classified | Office of Inspections and Investigations | Unapproved and Misbranded Drugs |
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