FDA 483 - JCB Laboratories LLC - September 14, 2018

An FDA inspection of JCB Laboratories LLC, an outsourcing facility, conducted from August 13-17, 20-24, and September 12-14, 2018, resulted in a Form FDA 483 outlining significant observations related to pharmaceutical manufacturing practices. The core issues included a critical lack of valid analytical and stability data to support beyond-use dates for various products, indicating insufficient testing to assure identity, strength, quality, and purity at the time of use. The facility also exhibited widespread deficiencies in its sterility assurance program, such as inadequate smoke studies, media fills that failed to simulate worst-case aseptic operations, and a lack of adherence to cleaning and environmental monitoring procedures. Furthermore, the inspection revealed systemic failures in quality control and investigation processes. This included untimely and incomplete investigations into out-of-specification test results, product complaints involving particulates and patient reactions, and sterility failures, often without proper corrective and preventive actions. The company also failed to follow its own standard operating procedures for change control, labeling, and adverse drug experience reporting. Other observations highlighted unsuitable storage conditions for drug products and raw materials, poor facility maintenance in the aseptic core, and inaccurate labeling on compounded products. JCB Laboratories is required to implement comprehensive corrective actions to address these critical deviations and ensure compliance with regulatory standards.