FDA Inspection
Oralten CorporationOralten Corporation – FDA Inspection, Jun 13, 2019
Record Details
This FDA Inspection record concerns Oralten Corporation, with an inspection on June 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e581cf00-7be9-4f66-bbbf-df16438f8553
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1092833
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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