FDA Inspection
Tedec-Meiji Farma, S.A.Tedec-Meiji Farma, S.A. – FDA Inspection, Nov 22, 2012
Record Details
This FDA Inspection record concerns Tedec-Meiji Farma, S.A., with an inspection on November 22, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tedec-Meiji Farma, S.A.
- Inspection Date
- November 22, 2012
- Product Type
- Drugs
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ID · e73b1703-ce33-4d0d-a4e4-78e8bcd6aa71
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 809541
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(b)input/output verification
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Tedec-Meiji Farma, S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 15, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| December 12, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tedec-Meiji Farma, S.A.
- FDA Inspection 996370 - 2016-12-15
- FDA Inspection 908026 - 2014-12-12
- FDA Inspection 741672 - 2011-07-22
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