FDA 483 - Molecular Products, Ltd. - February 14, 2019

Molecular Products, Ltd. in Barlow, Essex, United Kingdom, was inspected from February 11-14, 2019, and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in the firm's quality system, particularly concerning corrective and preventive actions, finished device acceptance procedures, equipment maintenance, and control of non-conforming products. These issues indicate a lack of adequate procedures and timely execution in critical quality control areas.