Company
United StatesCalimex USA Corporation, Gilroy, CA – FDA Inspections
Inspection records and compliance data for Calimex USA Corporation in Gilroy, California. 2 FDA inspections on record, last inspected February 24, 2014.
Company Profile
This profile covers Calimex USA Corporation based in Gilroy, California, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected May 22, 2013. Last inspected February 24, 2014.
Most cited issue areas
- Design plans - Lack of or inadequate1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 24, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 867311 |
| May 22, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 832426 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Calimex USA Corporation
FEI Number
3009596585
Address
1160 Bonino Way, Gilroy, California 95020, United States
Country
United States
ID: 0e143df3-6e30-419b-84b3-a2a6d5d8e394