FDA EIR - TTY Biopharm Company Limited Lioudu Factory - August 30, 2022

The FDA conducted a pre-approval inspection of TTY Biopharm Company Limited Lioudu Factory from August 22 to August 30, 2022. This inspection, carried out under the regulatory framework of Compliance Program 7346.832 for Pre-Approval Inspections, focused on the facility's readiness for commercial manufacturing, conformance to application, and data integrity for Amphotericin B Liposomes for Injection, ANDA 214010.

Upon completion, a four-item FDA 483 (Inspectional Observations) was issued. Key deficiencies noted included the failure to maintain reserve samples for submitted batches, inadequate management of environmental monitoring contact plates for an injectable production line, insufficient training of personnel on Current Good Manufacturing Practice (21 CFR 211) regulations, and the absence of hot water in specific hand washing areas and toilet facilities.

The firm's Senior Director of Production & Operation committed to providing a written response to the FDA 483 observations. The inspection was classified as Voluntary Action Indicated (VAI), signifying that the company is expected to implement corrective actions for the identified issues. Notably, an approval recommendation has been made for the Amphotericin B Liposomes for Injection, ANDA 214010, despite these observations.