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 3010680515.
Observations7
Issue DateJanuary 14, 2026
Status1 Related Warning Letter
Establishment TypeOutsourcing Facility
Related Inspections7
Establishment Details
Firm
US Specialty Formulations LLC
Location
Allentown, Pennsylvania, United States
FEI Number
3010680515
Establishment Type
Outsourcing Facility
Product Type
Drugs
Issue Date
January 14, 2026
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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