FDA WARNING_LETTER - The Regents of the University of Michigan Blood Bank - June 29, 2016

From June 6 to June 29, 2016, FDA investigators inspected the University of Michigan Medical Center, identifying serious deficiencies in sterile drug product production, leading to a Warning Letter. The facility's drug products were deemed adulterated under section 501(a)(2)(A) of the FDCA due to insanitary conditions.

Observed violations included: - Transferring components from ISO 7 cleanroom to ISO 5 hood without disinfection. - Poor aseptic practices by operators, such as resting gloved hands and gown sleeves in the ISO 5 working area. - Use of non-sterile wipes for cleaning ISO 5 hoods. - ISO 7 cleanroom surfaces (chairs, computer equipment, damaged floor seam, ceiling tiles) not being easily cleanable. - Failure to demonstrate adequate protection of the ISO 5 area through appropriate studies (e.g., lack of smoke studies under dynamic conditions).

The FDA reviewed the facility's July 15, 2016, response but found it lacking. Corrective actions for staff training, material transfer, and facility repairs were inadequately supported by documentation. The response also failed to address the lack of smoke studies and the use of non-sterile wipes.

The FDA strongly recommended a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance materials, and systems, particularly aseptic processing, with assistance from a third-party consultant.