483
Denison Pharmaceuticals, LLCFDA 483 - Denison Pharmaceuticals, LLC - October 25, 2017
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Record Details
Denison Pharmaceuticals, LLC in Lincoln, RI, was inspected by the FDA from October 17-25, 2017. The inspection identified a significant deficiency in the firm's Quality Control Unit, which failed to consistently follow its established procedures for handling customer complaints and adverse events. This indicates a breakdown in critical quality system processes related to complaint management.
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ID · 8581357a-2bb9-4dea-acbe-690a06c6bc36