FDA EIR - Unither Manufacturing LLC. - October 15, 2021

Unither Manufacturing LLC, based in Rochester, NY, underwent a preannounced FDA Good Manufacturing Practice (GMP) surveillance and pre-approval inspection from October 4 to October 15, 2021. The inspection assessed general drug GMP systems and readiness for a New Drug Application (NDA), operating under the regulatory framework of 21 CFR Parts 210 and 211.

The inspection identified five significant issues, resulting in an FDA Form 483. Main violations included the company's repeated failure to thoroughly review unexplained discrepancies, such as uninvestigated losses of differential pressure during aseptic filling and unaddressed errors in lot numbers on product packaging. Additionally, equipment and utensils were not maintained at appropriate intervals to prevent contamination, with examples like improperly stored purified water hoses and uncontrolled temporary ingredient containers.

Further observations noted that the quality control unit's responsibilities and procedures were not fully implemented, as seen in unreviewed exhibit batches and inadequate investigations of environmental monitoring deviations. The firm also lacked comprehensive written procedures for component approval, specifically concerning scientific testing for impurities. Lastly, deficiencies were found in the aseptic processing areas' environmental monitoring system, which lacked audible alarms for critical differential pressure changes. Unither Manufacturing LLC committed to voluntary corrections and a written response within fifteen business days. A withhold recommendation was issued for the NDA.