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 intermediates beyond the official or other established specifications.
Passage 2You failed to have adequate procedures for the cleaning and maintenance of manufacturing equipment and facilities. Our inspection found manufacturing equipment labeled as “Cleaned” and found the following deficiencies. For example:
Passage 3Failure of your quality unit to ensure that quality-related complaints are investigated and resolved.
Passage 4You failed to adequately investigate a complaint of **(b)(4)** particles in the intermediate, **(b)(4)**, Stage-**(b)(4)**, batch **(b)(4)**. The root cause was attributed to improper cleaning/usage of the **(b)(4)** bag. A CAPA to change the **(b)(4)** bag more frequently (i.e., after **(b)(4)** batches instead of **(b)(4)** batches) was proposed.
Passage 5Failure of your quality unit to exercise its responsibility to ensure the intermediates manufactured at your facility are in compliance with CGMP.