FDA 483 - Micro Quality Labs Inc - February 02, 2018

An FDA inspection of Micro Quality Labs Inc. in Burbank, CA, revealed significant deficiencies in laboratory controls, particularly concerning computerized systems, data integrity, and the handling of chemical reagents and stability samples. These issues, including a repeat observation from a previous inspection, indicate a serious lack of adherence to established standards for assuring the quality and purity of drug products.