Home / Compliance actions / 659142

FDA Warning Letter — US Specialty Formulations LLC

Case 659142 — FEI 3010680515

The FDA took a Warning Letter action against US Specialty Formulations LLC on July 26, 2023 (Allentown, PA). The action was issued by CDER and concerns drugs products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
US Specialty Formulations LLC
Date
July 26, 2023
Fiscal Year
2023
Product Type
Drugs
Center
CDER
Location
Allentown, PA (United States)

Facility

Recent inspections

  • 1265449 (VAI Wed Mar 26 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1243882 (OAI Tue Jul 02 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1167934 (OAI Tue Apr 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1097950 (OAI Tue Jul 23 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023411 (OAI Tue Aug 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Other compliance actions

FDA data resources