FDA 483 - Eagle Analytical Services, Inc. - December 17, 2019

Eagle Analytical Services, an analytical laboratory in Houston, TX, was inspected by the FDA and received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality control unit, aseptic processing areas, instrument calibration, and equipment cleaning procedures. These issues indicate a failure to maintain adequate control over laboratory operations and prevent potential contamination of drug products.