The FDA cited Kadesh International, a Garden Grove, California drug manufacturer, for serious violations observed at its facility including the lack of a quality control unit.
In an Oct. 19 to Nov. 7, 2018 inspection that resulted in a Form 483, the agency’s inspectors found the facility lacked adequate controls to prevent microbiological contamination of its products. For example, it used incoming components without ensuring their sterility. It also manufactured bulk drug substances and held components in rooms that didn’t have HEPA filtered air, positive air pressure, environmental monitoring or laminar air flow.
The facility failed to validate its cleaning process and it had no cleaning records for rooms or drug contact surfaces. The inspectors also noted that staff wore gowns that were not sterile.