Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1You did not perform adequate product evaluation and take appropriate corrective action after vermin was observed in your production area.
Passage 2You did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.
Passage 3An operator placed their gloved hands outside the ISO 5 area to retrieve supplies without sanitizing their gloved hands before re-entry into the ISO 5 hood.
Passage 4It is unclear where the insect light traps, air curtains, or vortex curtains will be installed in relation to the classified areas. Additionally, it is unclear when these corrective actions will be fully implemented.
Passage 5your response lacked supporting evidence, for example, you did not provide the retrospective review referenced. Furthermore, we acknowledge your response states, in SOP Compounded Sterile Product Impact Assessment Process, that a low risk level would be determined by the pharmacist in charge (PIC) based on the actionable microbial growth. Please note, any microbial contamination in the ISO 5 area is considered an insanitary condition.
Passage 6you did not provide the attachment Aseptic Technique Evaluation Update 04072022 referenced in your response.