1139875

Innova Medical Group, Inc. — FEI 3018074194

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 9, 2021
Fiscal Year
2021
Product Type
Devices
Project Area
Compliance: Devices
Location
Pasadena, CA (United States)

Citations

IDCFRDescription
1471121 CFR 820.160(a)Lack of or inadequate procedures for distribution
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
226921 CFR 820.20(a)Quality policy and objectives
232721 CFR 820.22Quality audits - Lack of or inadequate procedures
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313021 CFR 820.100(a)Lack of or inadequate procedures
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
366621 CFR 820.20(c)Management review - Lack of or inadequate procedures
47921 CFR 820.50Purchasing controls, Lack of or inadequate procedures
63021 CFR 803.17Lack of Written MDR Procedures