FDA 483 - MW Encap Ltd.(NextPharma Edinburgh) - December 14, 2018

Mw Encap Ltd. in Livingston, United Kingdom, was inspected and cited for significant deficiencies in its quality control laboratory. The inspection revealed inadequate controls over computerized systems, leading to concerns about data integrity, unauthorized data manipulation, and lack of proper data backup. Additionally, the firm failed to conduct necessary investigations for errors, retests, and out-of-specification results, further compromising the reliability of its electronic records.