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 3015156709.
Observations4
Issue DateApril 30, 2021
Status1 Related Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections2
Establishment Details
Firm
BPI Labs LLC
Location
Florida, United States
FEI Number
3015156709
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
April 30, 2021
Country
United States
Inspection History, 2025
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.