FDA Inspection
Healthfirst Corp. (Division of Polar)Healthfirst Corp. (Division of Polar) – FDA Inspection, Oct 30, 2013
Record Details
This FDA Inspection record concerns Healthfirst Corp. (Division of Polar), with an inspection on October 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 30, 2013
- Product Type
- Devices
View Company Profile
ID · 5a995ef3-3fd2-4636-935d-e408686f46b4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 853470
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(g)Design validation - software validation documentation
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
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