FDA Inspection
Fresenius Medical Care de Mexico, SA de CVFresenius Medical Care de Mexico, SA de CV – FDA Inspection, Dec 4, 2018
Record Details
This FDA Inspection record concerns Fresenius Medical Care de Mexico, SA de CV, with an inspection on December 4, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b74b2e6f-73fb-430f-b3a6-7cdbabfa9e35
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1076246
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of Fresenius Medical Care de Mexico, SA de CV
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 26, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 17, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fresenius Medical Care de Mexico, SA de CV
- FDA Inspection 983489 - 2016-07-26
- FDA Inspection 861884 - 2013-12-17
- FDA Inspection 561500 - 2009-01-30
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