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 3010943533.
Observations6
Issue DateNovember 14, 2025
Status1 Related Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections7
Establishment Details
Firm
Pine Pharmaceuticals, LLC
Location
Tonawanda, New York, United States
FEI Number
3010943533
Establishment Type
Outsourcing Facility
Product Type
Drugs
Issue Date
November 14, 2025
Country
United States
Inspection History, 2014 to 2025
NAI1
VAI1
OAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.
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