Home / Inspections / 1074463

1074463

Helena Laboratories, Corp. — FEI 1618982

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 14, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Beaumont, TX (United States)

Facility

Other inspections at this facility

  • 1018711 (OAI Fri Jul 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 820597 (VAI Fri Mar 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 694963 (VAI Fri Oct 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
322621 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
54621 CFR 820.75(a)Lack of or inadequate process validation