1290292

Akervall Technologies, Inc. — FEI 3011547262

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 6, 2025
Fiscal Year
2026
Product Type
Devices
Project Area
Compliance: Devices
Location
Saline, MI (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
310321 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
327021 CFR 820.80(c)Documentation
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
368321 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures