FDA Inspection
Akervall Technologies, Inc.Akervall Technologies, Inc. – FDA Inspection, Nov 6, 2025
Record Details
This FDA Inspection record concerns Akervall Technologies, Inc., with an inspection on November 6, 2025, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- Akervall Technologies, Inc.
- Inspection Date
- November 6, 2025
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 1d588234-9c21-45f7-a5b0-cca2146b6156
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1290292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
10- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.80(c)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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