FDA Inspection
Circle Prime Manufacturing Inc.Circle Prime Manufacturing Inc. – FDA Inspection, Mar 24, 2016
Record Details
This FDA Inspection record concerns Circle Prime Manufacturing Inc., with an inspection on March 24, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 24, 2016
- Product Type
- Devices
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ID · ea6cb0ce-8056-44d4-b0fe-cf346c7e6752
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964570
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.72(a)Equipment control activity documentation
- 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 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.50(a)(2)Supplier oversight
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