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1155210

Swabplus, L.P. — FEI 3003053677

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 15, 2021
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rancho Cucamonga, CA (United States)

Facility

Other inspections at this facility

  • 1211441 (OAI Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1087365 (NAI Thu Apr 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 989481 (VAI Thu Jun 30 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871965 (NAI Fri Mar 28 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 736574 (VAI Thu Jul 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
145021 CFR 211.113(a)Procedures for non-sterile drug products
189021 CFR 211.165(e)Test methods
360321 CFR 211.160(b)Scientifically sound laboratory controls
431421 CFR 211.84(d)(2)Reports of Analysis (Components)