FDA 483 - Theo Manufacturing BV - May 22, 2019

An FDA inspection of Thea Manufacturing BV in Maastricht, Netherlands, a manufacturer of L-Mesitran products, revealed significant deficiencies in their quality system. Observations included inadequate supplier control procedures, a lack of independent auditors for internal quality audits, and multiple issues related to the documentation of design controls. Specifically, design review results, design verification results, and design outputs were not adequately documented in the design history files for their products.