FDA 483 - Microbiological Consultants, Inc. - July 11, 2024

An FDA inspection of Microbiological Consultants Inc., a contract laboratory in Huntington, WV, revealed significant deficiencies. Observations included an inadequate number of qualified personnel, specifically only one analytical chemist for all chemical testing, and a lack of documented training for management overseeing microbiological lab records. Additionally, the firm failed to implement appropriate computer system controls, lacking unique user IDs and passwords for analytical instruments, leading to a lack of accountability for changes.