Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3011123993.
Observations3
Issue DateDecember 17, 2019
StatusNo Warning Letter
Establishment TypeProducer of Sterile Drug Products
Related Inspections4
Establishment Details
Firm
Infusion Systems of SW Florida Inc. dba Myerlee Pharmacy
Location
Fort Myers, Florida, United States
FEI Number
3011123993
Establishment Type
Producer of Sterile Drug Products
Product Type
Drugs
Issue Date
December 17, 2019
Country
United States
Inspection History, 2014 to 2022
VAI2
OAI2
VAI means Voluntary Action Indicated. OAI means Official Action Indicated.