FDA Inspection
Fairfield Orthodontics LLCFairfield Orthodontics LLC – FDA Inspection, Feb 28, 2013
Record Details
This FDA Inspection record concerns Fairfield Orthodontics LLC, with an inspection on February 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Fairfield Orthodontics LLC
- Inspection Date
- February 28, 2013
- Product Type
- Devices
View Company Profile
ID · b095afc1-3d6a-4d3c-a401-a201dfcfda65
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 822969
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 803.17Lack of Written MDR Procedures
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