FDA Inspection
Enamelite LLCEnamelite LLC – FDA Inspection, Nov 1, 2013
Record Details
This FDA Inspection record concerns Enamelite LLC, with an inspection on November 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Enamelite LLC
- Inspection Date
- November 1, 2013
- Product Type
- Devices
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ID · 2c3fd5b0-f1ee-444b-9d73-73b865f4e692
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 853715
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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