FDA Inspection
O.M. Performance, Inc. DBA PerSys MedicalO.M. Performance, Inc. DBA PerSys Medical – FDA Inspection, Aug 27, 2015
Record Details
This FDA Inspection record concerns O.M. Performance, Inc. DBA PerSys Medical, with an inspection on August 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 27, 2015
- Product Type
- Devices
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ID · 8dc3e740-746a-4d02-bf26-095a823a39b3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 940648
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
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