Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to clean, store, and sanitize equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.
Passage 2Failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure your API complies with established specifications and standards.
Passage 3Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.
Passage 4Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.