Company
MexicoFresenius Medical Care de Mexico, SA de CV, Zapopan, Mexico – FDA Inspections
Inspection records and compliance data for Fresenius Medical Care de Mexico, SA de CV in Zapopan. 4 FDA inspections on record, 1 Form 483, last inspected December 04, 2018.
Company Profile
This profile covers Fresenius Medical Care de Mexico, SA de CV based in Zapopan, Mexico.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 30, 2009. Last inspected December 4, 2018.
Most cited issue areas
- Procedures for sterile drug products1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 4, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1076246 |
| July 26, 2016 | VAI | Human Drugs · Drug Quality Assurance | 983489 |
| December 17, 2013 | VAI | Human Drugs · Drug Quality Assurance | 861884 |
| January 30, 2009 | NAI | Human Drugs · Drug Quality Assurance | 561500 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Fresenius Medical Care de Mexico, SA de CV
FEI Number
3007102377
Address
Paseo Del Norte 5300, Guadalajara Techology Park, Zapopan, Mexico
Country
Mexico
ID: a425662c-8722-4035-b4f4-5cf408ae88ac