FDA 483 - KP Pharmaceutical Technology - March 21, 2024

KP Pharmaceutical Technology, a manufacturer in Bloomington, IN, was inspected and received nine observations primarily related to significant deficiencies in aseptic processing, environmental monitoring, and quality control. The findings indicate a lack of established and followed procedures to prevent microbiological contamination, incomplete laboratory records, and inadequate investigations into batch failures. These issues suggest a high risk to the sterility and quality of drug products.