Company
MexicoGambro Renal Products S.A. de C.V., Tijuana, Mexico – FDA Inspections
Inspection records and compliance data for Gambro Renal Products S.A. de C.V. in Tijuana. 1 FDA inspection on record (1 OAI), last inspected February 19, 2009.
Company Profile
This profile covers Gambro Renal Products S.A. de C.V. based in Tijuana, Mexico.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 1
- VAI
- 0
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected February 19, 2009.
Most cited issue areas
- Lack of or inadequate process validation1 inspection
- Sampling plans1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 19, 2009 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 570585 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Gambro Renal Products S.A. de C.V.
FEI Number
3002806727
Address
Blvd. Pacifico 10014,, Parque Industrial Pacifico, Tijuana, Mexico
Country
Mexico
ID: a1f607a6-b213-4636-a7bc-1e403260b04b