FDA Inspection
Fresenius Medical Care de Mexico, SA de CVFresenius Medical Care de Mexico, SA de CV – FDA Inspection, Jul 26, 2016
Record Details
This FDA Inspection record concerns Fresenius Medical Care de Mexico, SA de CV, with an inspection on July 26, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 26, 2016
- Product Type
- Drugs
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ID · 0f78702b-3057-4467-a2fb-8324c10fbe03
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 983489
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.113(b)Procedures for sterile drug products
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Other FDA inspections of Fresenius Medical Care de Mexico, SA de CV
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2018 | 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 1076246 - 2018-12-04
- FDA Inspection 861884 - 2013-12-17
- FDA Inspection 561500 - 2009-01-30
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