988717

United Contact Lens, Inc. — FEI 2918644

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 12, 2016
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Arlington, WA (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472221 CFR 820.40Procedures not adequately established or maintained
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
312521 CFR 820.80(d)Lack of or inadequate final acceptance procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures