FDA 483 - Microbac Laboratories, Inc. - January 24, 2025

Microbac Laboratories, Inc. in Sterling, VA, a contract testing laboratory, received a Form 483 citing significant deficiencies in its quality system. The inspection revealed that the firm's investigations into out-of-specification and unexpected results were not thorough or fully documented, lacking conclusions and follow-up. Additionally, the quality control unit failed to ensure complete OOS investigation reports were reviewed and approved, a repeat observation from a previous inspection.