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FDA Inspection
•Epic Dental Studio•May 9, 2013

Epic Dental Studio – FDA Inspection, May 9, 2013

Record Details

This FDA Inspection record concerns Epic Dental Studio, with an inspection on May 9, 2013, issued by the Center for Devices and Radiological Health, covering devices.

Company
Epic Dental Studio
Inspection Date
May 9, 2013
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 7614152d-4259-4a5f-84e7-90906edd6a1e

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
832241
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.198(a)Complaints
  2. 21 CFR 820.100(a)Lack of or inadequate procedures
  3. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Epic Dental Studio

1
DateClassificationOfficeProject area
January 14, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Epic Dental Studio
  • FDA Inspection 970184 - 2016-01-14

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