Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to record all quality-related activities at the time they are performed.
Passage 2Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the APIs beyond the official or other established specifications.
Passage 3Failure to test the identity of each batch of incoming production material.