Sentry Biopharma Services, Inc. – FDA EIR, Jul 22, 2009

Sentry Biopharma Services, Inc., located in Indianapolis, IN, underwent an FDA inspection from July 20-22, 2009. This first inspection for the company, which performs warehousing, stability storage, and relabeling services for drug products, was conducted under Compliance Program 7356.002B, targeting Drug Repackagers and Relabelers. The review encompassed critical operational systems including Quality, Facilities & Equipment, Materials, and relevant aspects of Packaging & Labeling. Upon the inspection's conclusion, a two-point FDA Form 483, "List of Inspectional Observations," was issued. The main issues identified were the company's failure to adhere to all its own Quality Unit written procedures and a deficiency in performing finished product examinations of labeled drug products post-finishing operations. These observations indicated areas where Sentry Biopharma's quality control and operational adherence required immediate attention to meet regulatory standards. Management acknowledged the findings during the closeout meeting, verbally committing to implement corrective actions for each observation and promising a detailed written response to the District Office. This initial regulatory review highlighted the need for Sentry Biopharma to strengthen its procedural compliance and quality assurance processes.