FDA 483 - Microbac Laboratories, Inc. - May 24, 2021

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from May 5 to May 24, 2021, Microbac Laboratories, Inc., a contract testing laboratory located in Sterling, VA, received an FDA Form 483. The inspection revealed significant deficiencies in the firm's quality control unit and document management, particularly concerning the testing of crude cantharidin. The primary observation noted that the responsibilities and procedures for the quality control unit were not adequately documented in writing. Specific issues included unsecured storage of master files, such as out-of-specification (OOS) reports and equipment log sheets, making them accessible to unauthorized personnel. Furthermore, existing Standard Operating Procedures (SOPs) for OOS and unexpected results, along with the OOS reports themselves, lacked provisions for formal Quality unit review and signature. Calibration documents for critical equipment, including analytical balances and autoclaves used in cantharidin testing, also failed to include a Quality review and signature. These findings indicate a failure to adhere to established regulatory expectations for maintaining robust quality systems, as outlined by the Federal Food, Drug, and Cosmetic Act. Microbac Laboratories, Inc. is now required to address these inspectional observations by implementing comprehensive corrective actions to ensure proper quality oversight, secure document control, and appropriate review processes for critical testing and calibration records. This is crucial for demonstrating compliance and ensuring the reliability of their testing services.