FDA 483 - K.C. Pharmaceuticals, Inc. - November 16, 2017

An FDA inspection conducted from November 8-16, 2017, identified significant deficiencies in a drug manufacturing facility, whose name was not specified in the provided document. The inspection report, issued to James L. Medford, President/Chief Executive Officer, highlighted concerns across laboratory control, production, and quality systems, indicating non-compliance with the Federal Food, Drug and Cosmetic Act.

Key violations in the laboratory control system included inadequate computer access controls, where all analysts had System Administrator privileges on High-Performance Liquid Chromatography (HPLC) software, allowing raw data deletion. User roles for the Ultraviolet Spectrophotometer were undefined. The firm lacked procedures for reviewing HPLC audit trails, controlling and verifying Excel spreadsheet calculations used for critical analyses, and reconciling sample quantities. Additionally, logbooks were unbound, raising concerns about data integrity. Electronic raw data from critical laboratory instruments, such as the UV spectrophotometer and polarimeter, were not consistently maintained.

In the production system, an aseptic fill operator was observed with exposed forehead skin during sterile drug product filling, violating procedures to prevent microbiological contamination. Furthermore, the quality system failed to maintain video recordings of aseptic fill operations for the required duration, as these were automatically overwritten, impeding proper investigation of environmental excursions and media fill failures. The company must address these observations to ensure regulatory compliance and product quality.