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

An FDA inspection conducted at Microbiological Consultants Inc., a contract laboratory located in Huntington, WV, from July 9-11, 2024, resulted in the issuance of a Form FDA 483 document detailing significant observations. The primary issues identified pertain to personnel qualifications, supervisory oversight, and computer system controls. Specifically, the inspection revealed an inadequate number of qualified staff, with only one Analytical Chemist responsible for all chemical analytical testing. Furthermore, management responsible for supervising drug product processing lacked documented training or qualifications to oversee microbiological laboratory records, potentially impacting the assurance of product safety and quality. A critical observation also noted insufficient controls over computer systems used for analytical instruments, as analysts did not have unique user IDs or passwords, and administrative access was utilized without proper accountability, hindering traceability of modifications to methods and records. These observations, issued under the Federal Food, Drug, and Cosmetic Act, highlight practices that indicate non-compliance with regulatory expectations. Microbiological Consultants Inc. is required to promptly address these deficiencies by implementing comprehensive corrective actions to ensure operational integrity and regulatory compliance.