FDA 483 - Poly Pharmaceuticals, Inc - January 24, 2018

An FDA inspection of Poly Pharmaceuticals, Inc. in Owens Cross Roads, AL, an Own Label Drug Distributor, revealed a significant compliance issue regarding adverse drug experience reporting. The firm lacked written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse drug experiences. Furthermore, the firm's claim of not receiving any adverse drug experience reports for Ibudone tablets over the past six years could not be verified due to the absence of these procedures.