Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your facility lacked a certified ISO 5 classified area for sterile compounding.
Passage 2Your aseptic processing areas had difficult to clean and visibly dirty equipment and surfaces. For example: a. A (b)(4) hood, used to produce drug products purporting to be sterile, had a visibly dirty filter installed. Also, there was staining and peeling paint on the (b)(4) hood surfaces and supporting table.
Passage 3An air vent in the “IV storage and mixing room” was visibly dirty and part of the floor was covered with carpet.
Passage 4A refrigerator with dripping and standing water on the inside shelf was used to store sterile drug products used to produce IV therapy products. The containers/closures were in direct contact with the condensate water.
Passage 5Your firm distributed drug products that were prepared using expired components.