Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure of your quality unit to prepare, review, and approve documents related to the manufacturing of APIs in accordance with written procedures.
Passage 2Failure to properly maintain buildings and facilities used in the manufacture of APIs.
Passage 3You failed to maintain your facility in an acceptable state of repair. For example, investigators observed a room with **(b)(4)** liquid in a floor cavity surrounding the exit pipe of a **(b)(4)**. A similar liquid was dripping from a ceiling pipe junction in the **(b)(4)** area below this room. The liquid was dripping onto processing equipment labeled as clean and ready for use.
Passage 4Failure to establish an impurity profile for identified and unidentified impurities.