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 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 2Your firm failed to clean separation equipment **(b)(4)** used for the repackaging and relabeling of your **(b)(4)** API. This is also a repeat deviation from a previous inspection.
Passage 3Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of APIs and to use the results to confirm appropriate storage conditions and retest of expiry dates.
Passage 4Failure of your quality unit to exercise its responsibility to ensure the APIs manufactured at your facility are in compliance with CGMP.