FDA Inspection
Skidmore Medical LimitedSkidmore Medical Limited – FDA Inspection, Apr 12, 2017
Record Details
This FDA Inspection record concerns Skidmore Medical Limited, with an inspection on April 12, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- Skidmore Medical Limited
- Inspection Date
- April 12, 2017
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · c16cab0d-e03e-4446-930f-4e3b09d29547
Inspection Facts
- Inspection number
- 1023783
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.75(a)Documentation
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