828941

Huestis Machine Corporation — FEI 1219183

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 13, 2013
Fiscal Year
2013
Product Type
Devices
Project Area
Compliance: Devices
Location
Bristol, RI (United States)

Citations

IDCFRDescription
1471221 CFR 820.184DHR - not or inadequately maintained
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
232821 CFR 820.22Quality audits - auditor independence
311121 CFR 820.70(f)Buildings
312721 CFR 820.80(e)Documentation
333121 CFR 820.181DMR - not or inadequately maintained
500721 CFR 1002.13Failure to submit
54621 CFR 820.75(a)Lack of or inadequate process validation
571521 CFR 1002.41(a)(1)Forwarding, holding, preserving distribution data