Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3010680515.
Observations5
Issue DateMarch 26, 2025
Status1 Related Warning Letter
Related Inspections7
Establishment Details
Firm
US Specialty Formulations LLC
Location
Allentown, Pennsylvania, United States
FEI Number
3010680515
Product Type
Drugs
Issue Date
March 26, 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.
Talk to a Specialist