FDA EIR - Micro Quality Labs Inc - February 02, 2018

Micro Quality Labs, Inc., a contract control testing laboratory for OTC drug products, cosmetics, and dietary supplements, underwent an FDA inspection from January 24 to February 2, 2018. The inspection focused on the firm’s Quality System and Laboratory Control System. This was the first inspection at their current Burbank, CA location, though a previous inspection in 2014 at an older site had resulted in multiple observations related to lack of change management, investigation, computer access control, equipment logs, validation, and method validation. The current inspection identified a multi-part, one-item Form FDA 483 observation. The primary issue was that laboratory controls lacked scientifically sound specifications, standards, and test procedures to assure that components, in-process materials, and drug products conformed to appropriate quality and purity standards. Specific deficiencies included inadequate data security, where files on HPLC and GC instrument computers could be deleted or renamed, and files were found in the Recycle Bin. Furthermore, the audit trail for heavy metals testing equipment was incorrectly installed and non-functional, and expired chemical reagents were discovered in storage. In response, Micro Quality Labs' Co-Owner and Quality Assurance Technical Director committed to implementing corrections and submitting a written response to the FDA, addressing the deficiencies noted during the inspection.