FDA Inspection
Harbor Safety Products Group LLCHarbor Safety Products Group LLC – FDA Inspection, Mar 31, 2017
Record Details
This FDA Inspection record concerns Harbor Safety Products Group LLC, with an inspection on March 31, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1734b0ad-0847-49a3-ae66-b16c94f3f4d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006403
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.30(j)Design history file
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