FDA 483 - Span Packaging Services LLC - May 02, 2025

Span Packaging Services LLC, a contract manufacturer in Greenville, SC, was inspected and cited for significant deficiencies in its manufacturing and laboratory controls. Observations included a lack of established procedures, environmental monitoring, and validations for sterile drug products, as well as inadequate laboratory testing for finished products and unverified bulk product testing methods. The firm also failed to thoroughly review unexplained discrepancies and out-of-specification stability failures, lacking proper root cause analysis.