US FDA Aseptic processing and sterility assurance findings

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Aseptic processing areas deficient regarding system for monitoring environmental conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

The phlebotomy site is not prepared by a method that gives maximum assurance of a sterile container of Whole Blood.

Your firm failed to perform adequate airflow visualization studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Your airflow visualization studies are deficient because: a. The studies do not clearly demonstrate that the airflow pattern sweeps over and away from the critical areas near and on the ISO 5 classified LAF hood work surface where aseptic operations occur. Instead, the smoke appears to arc out of the hood significantly higher than the critical area and then travel up toward the ceiling in the surrounding ISO 7 classified area. b. In your most recent airflow visualization study VAL-25-044-FR, you indicated that (b)(4) people are allowed in ISO 7 (b)(4) Room (b)(4) during aseptic operations; however, the smoke study videos provided during the FDA inspection only include a maximum of (b)(4) people, and fail to demonstrate that airflow patterns inside the ISO 5 classified critical areas are not impacted by a large number of personnel moving inside cleanroom Room (b)(4) . The FDA investigator also collected evidence indicating CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example…