1175810

Allison Medical, Inc. — FEI 1000138447

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 29, 2022
Fiscal Year
2022
Product Type
Devices
Project Area
Compliance: Devices
Location
Littleton, CO (United States)

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
1472221 CFR 820.40Procedures not adequately established or maintained
312021 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
313021 CFR 820.100(a)Lack of or inadequate procedures
419121 CFR 806.10(a)(1)Report of risk to health
443621 CFR 803.40(a)Report of death, injury
48621 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements