FDA EIR - Winder Laboratories, LLC - June 09, 2017

An FDA cGMP inspection of Winder Laboratories, LLC, located in Winder, GA, was conducted from June 5-9, 2017, focusing on their unapproved drug product, Phenohytro Tablets. This inspection, carried out under CP 7356.002, Drug Manufacturing Inspections, followed up on a previous assessment (November-December 2015) that resulted in ten objectionable conditions. These prior issues included deficiencies in quality control responsibilities, laboratory control mechanisms, control of rejected components, equipment calibration and design, employee training content and frequency, warehousing procedures, and the completeness and review of laboratory records. While the current inspection did not result in an FDA Form 483, indicating a general improvement in formal compliance, the inspector engaged in discussions with management regarding several critical areas. These areas encompassed the verification of audit trails, user access levels for laboratory instruments, clarity of material status labels, and adherence to good documentation practices. A notable observation was the ability to delete chromatogram data files within the HPLC operating system, which presents a data integrity concern. The inspection also highlighted inconsistent practices in marking material status labels and the absence of a second-person verification for retain sample inventory logs. Although no formal citations were issued, these discussions and observations signal ongoing areas where Winder Laboratories must enhance its adherence to current Good Manufacturing Practices.