US Specialty Formulations, LLC – FDA Warning Letter, Apr 26, 2022

On July 26, 2023, the FDA issued Warning Letter #659142 to US Specialty Formulations LLC, an outsourcing facility located in Allentown, PA. The letter followed an inspection from March 21 to April 26, 2022, which revealed serious deficiencies in the production of sterile drug products and failure to meet Section 503B of the FDCA conditions.

Violations included misbranding due to inadequate labeling (missing dosage form, active/inactive ingredients, and quantities) and failure to submit adverse event reports according to 21 CFR 310.305. The facility's drug products were deemed adulterated under Section 501(a)(2)(A) due to insanitary conditions, such as using non-sterile wipes in ISO 5 areas, blocked first air, inadequate smoke studies, and improper material disinfection during transfer.

Additionally, numerous CGMP violations under Section 501(a)(2)(B) were cited, including failure to maintain adequate air supply, lack of validated aseptic procedures, inadequate cleaning/disinfection, unsuitable facility size/construction, insufficient sterility testing, improper personnel clothing, inadequate environmental monitoring, and poor investigation of discrepancies. The compounded drugs were also considered unapproved new drugs and misbranded under Sections 505(a) and 502(f)(1) of the FDCA, respectively, as they lacked