FDA Inspection
Guna S.p.A.Guna S.p.A. – FDA Inspection, Dec 2, 2016
Record Details
This FDA Inspection record concerns Guna S.p.A., with an inspection on December 2, 2016, issued by the Office of Inspections and Investigations, covering human drugs.
- People
- June P. Page (FDA Associated Person)
- Marie B. Buen-Bigornia (Issuing Officer)
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ID · e3c15908-37f5-45a7-928b-f87c61c02a30
Inspection Facts
- Inspection number
- 999222
- FDA center
- Human Drugs
- Project area
- Unapproved and Misbranded Drugs
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.122(a)Sampling/testing of labeling/packaging materials
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.182Written records kept in individual logs
- 21 CFR 211.194(a)(4)Complete Test Data
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Guna S.p.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2014 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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