FDA Inspection
Skil-Care CorpSkil-Care Corp – FDA Inspection, Jul 21, 2015
Record Details
This FDA Inspection record concerns Skil-Care Corp, with an inspection on July 21, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Skil-Care Corp
- Inspection Date
- July 21, 2015
- Product Type
- Devices
View Company Profile
ID · 0b01a1b1-4f9f-4d6e-948f-5da97e7b2dc1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938032
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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