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713089

Lyne Laboratories, Inc. — FEI 1000513191

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 25, 2011
Fiscal Year
2011
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))
  • 1038819 (VAI Thu Jan 25 2018 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))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
181021 CFR 211.160(a)Lab controls established, including changes
197621 CFR 211.182Specific information required in individual logs
240121 CFR 211.194(a)(4)Complete Test Data
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.
440321 CFR 211.194(b)Test method modification records do not include