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.
Observations1
Issue DateFebruary 21, 2025
Status1 Related Warning Letter
Establishment TypeSterile Drug Manufacturer
Related Inspections2
Establishment Details
Firm
BPI Labs, LLC
Location
Largo, Florida, United States
FEI Number
3015156709
Establishment Type
Sterile Drug Manufacturer
Product Type
Drugs
Issue Date
February 21, 2025
Country
United States
Inspection History, 2025
NAI1
VAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated.