FDA EIR - Winder Laboratories, LLC - July 18, 2018

An FDA inspection of Winder Laboratories, LLC in Winder, Georgia, was conducted from July 9-18, 2018, encompassing both Pre-Approval Inspection and cGMP surveillance. This inspection identified thirteen significant observations on a Form FDA 483, including numerous repeat findings from previous inspections in 2015 and 2017. The main issues centered on a deficient quality control unit, inadequate laboratory controls, and poor data integrity practices. Specifically, the firm failed to fully follow quality control procedures, lacked proper establishment and approval of laboratory control mechanisms, and exhibited inadequate controls over computer systems, allowing sensitive user privileges. Laboratory records were consistently incomplete, missing data, and lacking proper review signatures. Equipment and facilities also presented major concerns, with issues such as uncalibrated stability chambers, an ineffective equipment cleaning program leading to potential cross-contamination, and a general lack of equipment identification, qualification, and proper movement procedures. The facility also suffered from unsanitary conditions, including insect infestation. Furthermore, employee training in operations and cGMP was insufficient, and critical documents like product validations and quality agreements were not provided. Two commercial drug products, Phenohytro® Tablet and Elixir, were identified as un-approved. These observations underscore a systemic failure to adhere to Current Good Manufacturing Practices. Winder Laboratories, LLC is required to submit a written response to the FDA 483 within 15 business days, detailing comprehensive corrective and preventive actions to address all deficiencies and ensure regulatory compliance.