Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Vermin were observed in an area immediately adjacent to the firm’s production area.
Passage 2Production areas were difficult to clean or contain porous, particle generating, or visibly dirty surfaces. Specifically, debris on the floor, peeling (b)(4) tape with an apparent build-up of black residue on the floor in the ISO 7 cleanroom, and black residue build-up around (b)(4) HEPA filters were observed.
Passage 3An operator blocked first air by placing gloved hands directly over open sterile containers.
Passage 4HEPA filters were not sealed around each perimeter to the support frame.
Passage 5Personnel failed to disinfect gloves and components to prevent contamination.
Passage 6Personnel donned gowning apparel improperly in a way that may have caused the gowning apparel to become contaminated.
Passage 7Your firm handled hazardous drug products without providing adequate cleaning of utensils to prevent cross-contamination.