FDA 483 - Reed-Lane, Inc. - March 03, 2023

An FDA inspection of Reed-Lane, Inc., a drug packager in Wayne, NJ, revealed significant deficiencies in its quality control unit, particularly regarding change control and temperature mapping. The firm also failed to adequately investigate product complaints for missing lot numbers and expiry dates, and its equipment cleaning procedures were found to be deficient. These issues indicate a lack of robust quality system oversight.