FDA Inspection
Enhancement Medical, LLCEnhancement Medical, LLC – FDA Inspection, Jan 15, 2014
Record Details
This FDA Inspection record concerns Enhancement Medical, LLC, with an inspection on January 15, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Enhancement Medical, LLC
- Inspection Date
- January 15, 2014
- Product Type
- Devices
View Company Profile
ID · b1a66e07-2c2f-4834-9d02-06b52863d7c4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 863009
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)(1)Documented evaluation
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