FDA Inspection
Mike's Mouthpieces and Custom Oral AppliancesMike's Mouthpieces and Custom Oral Appliances – FDA Inspection, Sep 26, 2013
Record Details
This FDA Inspection record concerns Mike's Mouthpieces and Custom Oral Appliances, with an inspection on September 26, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 26, 2013
- Product Type
- Devices
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ID · 15839d1e-5b1a-482d-9d2c-1e66424a962c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 850715
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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