Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to ensure that equipment is maintained.
Passage 2Failure to properly maintain buildings and facilities used in the manufacture of API.
Passage 3You failed to maintain your drug manufacturing facility in a good state of repair. Specifically, our investigator observed the following deficiencies in the **(b)(4)** production building during the inspection: