FDA Inspection
Tedec-Meiji Farma, S.A.Tedec-Meiji Farma, S.A. – FDA Inspection, Dec 15, 2016
Record Details
This FDA Inspection record concerns Tedec-Meiji Farma, S.A., with an inspection on December 15, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 08ab45d9-75fe-4b73-ad86-87d50403df04
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 996370
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Tedec-Meiji Farma, S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| July 22, 2011 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Tedec-Meiji Farma, S.A.
- FDA Inspection 908026 - 2014-12-12
- FDA Inspection 809541 - 2012-11-22
- FDA Inspection 741672 - 2011-07-22
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