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1182001

Lyne Laboratories, Inc. — FEI 1000513191

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 21, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Brockton, MA (United States)

Facility

Other inspections at this facility

  • 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))
  • 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
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
135821 CFR 211.100(b)SOPs not followed / documented
136121 CFR 211.100(a)Absence of Written Procedures
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
356521 CFR 211.58Buildings not maintained in good state of repair