Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to adequately validate written procedures for the cleaning and maintenance of equipment.
Passage 2You failed to adequately validate cleaning procedures for your non-dedicated manufacturing equipment to ensure it is fit for its intended use. You also failed to properly maintain your equipment as they were observed to be in a state of disrepair.
Passage 3Failure to demonstrate your manufacturing process can reproducibly produce an API that meets its predetermined quality attributes. Also, there is no assurance that your facilities, equipment, and testing methods are suitable for their intended use.
Passage 4Your firm failed to establish a protocol and implement a plan to ensure all API manufacturing processes, equipment and facilities are fit for use. For example,
Passage 5Failure to design a documented, on-going 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 6Failure to prepare, review, and approve documents related to the manufacturing of API in accordance with written procedures.
Passage 7Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.