FDA Inspection
Black & Black Surgical IncBlack & Black Surgical Inc – FDA Inspection, Apr 20, 2016
Record Details
This FDA Inspection record concerns Black & Black Surgical Inc, with an inspection on April 20, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Black & Black Surgical Inc
- Inspection Date
- April 20, 2016
- Product Type
- Devices
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ID · 15f05195-1c26-46d4-9351-1b51c4098e1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 981903
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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