New York Facility Receives FDA Warning Letter

FDA sent a warning letter, dated May 14, 2019, to Kingston Pharma LLC after an inspection of the company’s Massena, New York facility found violations of current good manufacturing practices (CGMPs). The violations included inadequate quality and process control and improper building maintenance.

The inspection, which was conducted from November 13 to December 10, 2018, found the company had failed to establish adequate written quality control procedures. According to FDA, product batches were distributed before all test results were reviewed. “In addition, you have no written documentation describing your audit trail review procedure. During the inspection, your [quality unit] personnel could not show the audit trails on your high-performance liquid chromatography (HPLC) instruments. In your response, you acknowledged that before the FDA inspection, you released some batches ‘on a risk basis while awaiting results’,” the agency stated in the letter. The agency asked that the company provide a retrospective evaluation of distributed batches to determine identity and strength of API.

The letter also stated that the company did not validate manufacturing processes, and some of those processes were missing key parameters. Also, manufacturing equipment was not qualified. FDA asked the company to provide a risk assessment of products on the market and a validation plan for ensuring product control.

An adequate, written stability testing program was also not established, according to the agency. The company failed to evaluate if drug products had adequate supporting stability data. FDA asked the company to provide a retrospective review of all missing or delayed stability testing, an impact assessment for the missed or delayed stability testing, a corrective action and preventive action plan (CAPA) to ensure an adequate stability program, and a program for determining shelf life of products.

During the inspection, investigators also observed peeling sealant in ceilings directly above filling machines and cracked light fixtures over dispensing areas. While the company stated it had made repairs to the facility, it did not provide FDA with evidence of the repairs or a plan for performing checks of the facility’s condition. The agency requested a review of the company’s preventive maintenance programs and a CAPA for ensure the program’s effectiveness.

Source: FDA