FDA 483 - Daane Labs - September 19, 2025

An FDA inspection of Daane Labs, a contract testing laboratory, was conducted from September 15-19, 2025, revealing significant deficiencies in their operations. Key issues included inadequate laboratory controls for media preparation, where the firm failed to follow written procedures and manufacturer instructions, used media that did not meet established pH specifications, and lacked scientific justification for media expiration dating. The quality control unit also showed critical weaknesses in data integrity and documentation practices, such as unsecured electronic system access, uncontrolled Excel spreadsheets permitting data manipulation, approval of media without verification, and unmanaged disposal of laboratory documents. Additionally, the company conducted incomplete investigations into equipment discrepancies, like incubator temperature excursions, without assessing the impact on microbiological samples or providing scientific justifications for observed deviations. Finally, laboratory records were deficient, as certificates of analysis did not include established specifications or indicate if test results were within acceptable ranges. Daane Labs is required to address these observations promptly to ensure compliance with regulatory standards for drug product testing.