FDA EIR - USpharma Ltd - February 16, 2023

An abbreviated Good Manufacturing Practice (GMP) surveillance inspection of USpharma Ltd, a drug manufacturer of transdermal patches and soft chewable tablets, was conducted by the FDA in Miami Lakes, FL, from February 13 to February 16, 2023. This inspection was performed under the regulatory framework of CP 7356.002, Drug Manufacturing Inspections. Originally planned as a pre-approval inspection, its scope changed to surveillance after the facility was withdrawn as an alternate packaging site for a specific product.

During the inspection, no formal written observations (FDA-483) were issued. However, discussions with management during the closing meeting highlighted several areas for improvement. These included a repeated deficiency concerning blank spaces in the logbook for scale verification in the dispensing room, and an instance where a procedure was not consistently followed. Additionally, the calibration of temperature and relative humidity sensors in the stability chambers was noted as lacking comprehensive linearity and repeatability tests. A minor facility issue, a blown-out light bulb, was promptly corrected during the inspection.

The FDA evaluated the voluntary corrective actions taken by USpharma in response to three deficiencies cited during a previous inspection in June 2022, finding them appropriate. These prior issues related to inadequate method validation, inaccurate reporting of unspecified peaks, and insufficient investigation into out-of-trend results. Management was reminded of their responsibility to maintain continuous compliance with all applicable laws and regulations.