JP Packaging L.L.C. – FDA 483, Oct 29, 2025

An FDA inspection of ECOTR, a repackager/repacker in Chester, NY, conducted from October 27-29, 2025, identified significant deficiencies in the firm's operations. The inspection, carried out under the Federal Food, Drug and Cosmetic Act, resulted in several observations documented on an FDA Form 483, indicating a need for substantial corrective actions.

Key issues included the absence of written procedures for critical quality control functions, such as change control, out-of-specification (OOS) investigations, deviation processes, and corrective and preventive actions (CAPAs). Inspectors also noted that drug products were not stored under appropriate temperature and humidity conditions, specifically citing the lack of seasonal temperature mapping studies for receiving, production, and shipping warehouses. Furthermore, written cleaning and maintenance procedures were deemed inadequate, failing to include parameters relevant to equipment cleaning when idle. Lastly, calibration records for production balances were deficient, as they did not include data for repeatability testing.

To address these observations, ECOTR must establish comprehensive written quality control procedures, implement thorough temperature monitoring and mapping studies, revise and validate cleaning protocols, and ensure all equipment calibration records are complete, including repeatability data. These measures are essential for achieving compliance with regulatory standards and assuring product quality and safety.