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1008513

Maser Industries, LLC — FEI 3006793126

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 6, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lenexa, KS (United States)

Facility

Other inspections at this facility

  • 1264271 (NAI Thu Mar 06 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181647 (NAI Thu Sep 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1077026 (VAI Thu Jan 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031246 (OAI Thu Nov 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 911150 (NAI Thu Jan 15 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117321 CFR 110.40(f)Q.C. instrument accuracy, maintenance
1541021 CFR 111.14(b)(2)Personnel - records - training
1553221 CFR 111.255(b)Batch record - complete
1576321 CFR 111.205(a)Master manufacturing record - unique formulation
1589721 CFR 111.83(a)Reserve sample - collect, hold
166521 CFR 110.80(a)(2)Pasteurization or other adequate treatment
307121 CFR 114.80(a)(1)Scheduled process
307821 CFR 114.80(b)Code - required elements
447021 CFR 108.25(c)(2)Process filing