483
SigmaPharm Laboratories LLCFDA 483 - SigmaPharm Laboratories LLC - December 17, 2025
Record Details
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.
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ID · 818e7c64-f462-402d-b9d1-f97cfbf1bc74