FDA Inspection
Duerr Dental SEDuerr Dental SE – FDA Inspection, Sep 11, 2019
Record Details
This FDA Inspection record concerns Duerr Dental SE, with an inspection on September 11, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 58cf4f1c-880d-40ad-b0b4-1a21d4e25f4c
Inspection Facts
- Inspection number
- 1101667
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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