FDA 483 - SigmaPharm Laboratories LLC - December 17, 2025

During an FDA inspection, SigmaPharm Laboratories LLC, a non-sterile finished drug manufacturer in Bensalem, PA, was cited for inadequate investigation procedures. The firm failed to expand the scope of an investigation into foreign plastic fragments found in a rejected drug lot. This lapse meant that a retrospective review of other drug products potentially affected by the same non-procedural modification was not conducted, indicating a significant quality control concern.