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1211441

Swabplus, L.P. — FEI 3003053677

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 1, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Rancho Cucamonga, CA (United States)

Facility

Other inspections at this facility

  • 1155210 (OAI Fri Oct 15 2021 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
117721 CFR 211.63Equipment Design, Size and Location
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
145021 CFR 211.113(a)Procedures for non-sterile drug products
176721 CFR 211.137(a)Expiration date lacking
184321 CFR 211.84(d)(2)Component written specification
356521 CFR 211.58Buildings not maintained in good state of repair
360221 CFR 211.160(a)Deviations from laboratory control requirements
360321 CFR 211.160(b)Scientifically sound laboratory controls