Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Your firm failed to use a sporicidal agent as part of your disinfection program for the aseptic processing area and used non-sterile wipes to clean within the area where drug products were filled into syringes.
Citations in the original letter
As cited in this historical letter, not a statement of current regulatory requirements.
- 21 CFR 201.115