FDA Inspection
Dentaline LLCFDA Inspection 1147335 - Dentaline LLC - July 29, 2021
Record Details
This FDA Inspection record concerns Dentaline LLC, with an inspection on July 29, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dentaline LLC
- Inspection Date
- July 29, 2021
- Product Type
- Devices
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ID · ef22580a-512e-4d56-8d55-e6ecdf3862fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147335
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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