FDA Inspection
MEDA Manufacturing GmbHMEDA Manufacturing GmbH – FDA Inspection, Sep 7, 2017
Record Details
This FDA Inspection record concerns MEDA Manufacturing GmbH, with an inspection on September 7, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 6bf59010-b425-411e-9913-f2f01e5ef611
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1024520
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of MEDA Manufacturing GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| November 22, 2013 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 30, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for MEDA Manufacturing GmbH
- FDA Inspection 990063 - 2016-09-09
- FDA Inspection 872188 - 2013-11-22
- FDA Inspection 560082 - 2009-01-30
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