FDA Inspection
Ad Rem TechnologyAd Rem Technology – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns Ad Rem Technology, with an inspection on November 2, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Dave M. Deroche (Issuing Officer)
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ID · 9265f849-db20-42f6-a390-e310e981e055
Inspection Facts
- Inspection number
- 1030501
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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