Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API and intermediates complies with established specifications and standards.
Passage 2Failure of your quality unit to ensure that drugs are appropriately tested and the results are reported.
Passage 3You failed to establish a quality unit (QU), including defining responsibilities and procedures applicable to a QU. Additionally, when asked during the inspection whether you track any deviations and laboratory errors, you responded that you only provide testing results. Your laboratory director stated that the firm is not involved in CGMP activities, however, your customers used your data for CGMP purposes.