FDA 483 - Element Materials Technology Canada Inc. - October 18, 2019

Element Materials Technology Canada, Inc., a control testing laboratory in Mississauga, received two observations during an FDA inspection. The observations highlight deficiencies in documenting second-person review of electronic laboratory records, particularly for HPLC data, and inadequate root cause determination in non-conformance investigations. These issues point to concerns with data integrity and the effectiveness of the quality control unit's procedures.