FDA Inspection
Mecamed CorporationMecamed Corporation – FDA Inspection, Jun 18, 2013
Record Details
This FDA Inspection record concerns Mecamed Corporation, with an inspection on June 18, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mecamed Corporation
- Inspection Date
- June 18, 2013
- Product Type
- Devices
View Company Profile
ID · a4868799-051d-4cd6-969f-a9970a487fec
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 836331
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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