USpharma, Ltd., Co. – FDA EIR, Jun 23, 2022

An FDA cGMP inspection of USpharma Ltd, a manufacturer of transdermal and topical drug patches and gummies, was conducted from June 13 to June 23, 2022, in Miami Lakes, FL. This was the firm's initial inspection, covering Quality, Production, Materials, and Laboratory systems under Compliance Program 7356.002, Drug Manufacturing Inspections. The inspection focused on products such as Nitro-Dur, Lidocaine 4% Gel Patch, and Diphenhydramine HCl Chewable Bars. The inspection identified several deficiencies, leading to the issuance of an FDA-483 form with three primary observations. These included inadequate method validation for degradant products of Nitro-Dur, specifically lacking a detection limit; inaccurate reporting of unspecified peaks in analytical results; and a general lack of thorough investigations into out-of-trend, suspect, or aberrant laboratory results. Verbal observations also highlighted issues such as storing clean and dirty equipment in uncleaned manufacturing rooms, inadequate inventory record-keeping, and insufficient justification within change control reports. The firm’s management committed to addressing these observations and providing a written response within fifteen business days, signaling the need for comprehensive corrective actions to ensure full compliance with good manufacturing practices.