FDA Inspection
RESET TECHNOLOGY CORPORATIONRESET TECHNOLOGY CORPORATION – FDA Inspection, Dec 20, 2024
Record Details
This FDA Inspection record concerns RESET TECHNOLOGY CORPORATION, with an inspection on December 20, 2024, issued by the New Jersey District Office, covering medical devices & rad health.
- Company
- RESET TECHNOLOGY CORPORATION
- Inspection Date
- December 20, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 69b17631-f17f-4ff9-bc85-f4f89eee3bca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1257116
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
12- 21 CFR 820.70(g)Equipment design and installation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.70(i)Software validation for automated processes
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