Home / Inspections / 1038819

1038819

Lyne Laboratories, Inc. — FEI 1000513191

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 25, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brockton, MA (United States)

Facility

Other inspections at this facility

  • 1182001 (VAI Fri Oct 21 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1152572 (NAI Wed Sep 08 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026803 (NAI Thu Sep 07 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 983497 (VAI Wed Aug 17 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 865986 (VAI Thu Feb 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
135821 CFR 211.100(b)SOPs not followed / documented