FDA Inspection
Laboratorio Genove SALaboratorio Genove SA – FDA Inspection, Sep 9, 2022
Record Details
This FDA Inspection record concerns Laboratorio Genove SA, with an inspection on September 9, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Laboratorio Genove SA
- Inspection Date
- September 9, 2022
- Product Type
- Drugs
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ID · bd9a49bb-be94-4f7b-944d-ef28bb9051e2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1179131
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.100(a)Absence of Written Procedures
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Other FDA inspections of Laboratorio Genove SA
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Laboratorio Genove SA
- FDA Inspection 983620 - 2016-06-09
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