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911783

Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy — FEI 3011123993

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 22, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Fort Myers, FL (United States)

Facility

Other inspections at this facility

  • 1177452 (VAI Thu Aug 11 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1113003 (VAI Tue Dec 17 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018509 (OAI Thu Jul 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
116221 CFR 211.28(a)Protective Apparel Not Worn
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
144821 CFR 211.111Establishment of time limitations
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
176721 CFR 211.137(a)Expiration date lacking
184921 CFR 211.84(d)(6)Objectionable microbiological contamination
188321 CFR 211.165(a)Testing and release for distribution
193321 CFR 211.167(a)Sterility/pyrogens - test methods written, followed