FDA 483 - Almac Clinical Services, LLC - December 22, 2017

Almac Clinical Services, LLC in Souderton, PA, a contract testing lab, was cited for deficiencies in its quality control unit during an FDA inspection. The firm failed to ensure the timely review of standard operating procedures (SOPs). Multiple site-specific and Almac Sciences procedures were found to be significantly overdue for review, indicating a lapse in document management and quality system adherence.