FDA 483 - Cook Biotech Incorporated - February 11, 2022

Parsolex GMP Center, Inc. in West Lafayette, IN, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies and initiate investigations for deviations, such as delayed or missing equipment entries. Additionally, procedures for equipment cleaning and maintenance were found to be deficient, lacking sufficient detail and proper documentation, and computer system controls were inadequate to ensure data integrity.