FDA Inspection
Tedec-Meiji Farma, S.A.Tedec-Meiji Farma, S.A. – FDA Inspection, Jul 22, 2011
Record Details
This FDA Inspection record concerns Tedec-Meiji Farma, S.A., with an inspection on July 22, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tedec-Meiji Farma, S.A.
- Inspection Date
- July 22, 2011
- Product Type
- Drugs
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ID · 5cdcd4fb-2023-4ad1-bfd8-1e2bdeafa34a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 741672
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully 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 |
| November 22, 2012 | VAI | 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 809541 - 2012-11-22
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