FDA Inspection
Calimex USA CorporationCalimex USA Corporation – FDA Inspection, May 22, 2013
Record Details
This FDA Inspection record concerns Calimex USA Corporation, with an inspection on May 22, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Calimex USA Corporation
- Inspection Date
- May 22, 2013
- Product Type
- Devices
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ID · 3bf211d6-67be-4761-bafc-2cdd7c75b50c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832426
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Calimex USA Corporation
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 24, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Calimex USA Corporation
- FDA Inspection 867311 - 2014-02-24
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