FDA Inspection
Harps Europe ManufacturingHarps Europe Manufacturing – FDA Inspection, May 28, 2010
Record Details
This FDA Inspection record concerns Harps Europe Manufacturing, with an inspection on May 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Harps Europe Manufacturing
- Inspection Date
- May 28, 2010
- Product Type
- Devices
View Company Profile
ID · 870b4446-e23f-4d91-860d-a68f269e79b4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 669646
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.70(b)Verification or validation of changes
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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