FDA Inspection
Promex Technologies, LLCPromex Technologies, LLC – FDA Inspection, Jul 27, 2011
Record Details
This FDA Inspection record concerns Promex Technologies, LLC, with an inspection on July 27, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Promex Technologies, LLC
- Inspection Date
- July 27, 2011
- Product Type
- Devices
View Company Profile
ID · 5e0be594-6011-4d41-9bf0-1855c0051d23
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 741068
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 803.17Lack of Written MDR Procedures
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