FDA Inspection
Ordont Orthodontic Laboratories IncOrdont Orthodontic Laboratories Inc – FDA Inspection, Feb 8, 2024
Record Details
This FDA Inspection record concerns Ordont Orthodontic Laboratories Inc, with an inspection on February 8, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c2ef2792-2b00-436e-a885-337361fb9233
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1228986
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
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