Texas Compounder Draws Warning Letter for Sterility Lapses
North American Custom Laboratories earned an FDA warning letter for failing to prove it had corrected manufacturing problems that could have impaired product sterility.
The warning stemmed from an inspection in March 2022 of the Texas compounding facility that resulted in a Form 483 for numerous disinfection and sterility issues. While the company did address the problems, the FDA said it didn’t provide enough documentation to prove that the remediation was effectively carried out.
The 483 noted an inappropriate sterilization device; inadequate cleaning, disinfection and airflow testing processes; and an unidentified “pink residue on the ceiling, vents and walls in [the] production area.”
The letter called on the company to undertake “a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems,” particularly its aseptic processing operations. The FDA also said the company should hire a third-party consultant with relevant sterile drug processing expertise to help with the assessment.