FDA EIR - Purdue Pharmaceuticals LP - August 24, 2017

A routine FDA surveillance inspection was conducted at Purdue Pharmaceuticals Lp in Wilson, NC, from August 21-24, 2017. The inspection, guided by CPGM 7356.002 for Drug Manufacturing Inspections, employed a systems-based approach, reviewing Quality, Materials, Packaging and Labeling, Production, Facilities and Equipment, and aspects of Laboratory Controls. No formal inspectional observations (FDA Form 483) were issued; however, three procedural items were discussed with company management. Firstly, the firm lacked a system for trending manufacturing defects ejected from production lines and did not provide specific training for operators to consistently identify these defects. Management committed to evaluating these process improvement initiatives and assessing the need for formalized defect training. Secondly, an existing standard operating procedure (SOP) for monitoring stability chambers required a deviation for temperature excursions even when equipment was known to be out-of-service; the firm agreed to evaluate updating this SOP to include an appropriate exclusion. Lastly, a Quality Control Transfer Voucher form for stability samples was identified as redundant, duplicating information already recorded in the Laboratory Information Management System (LIMS). Management promptly decided to discontinue the use of this duplicative form for stability sample transfers. The inspection concluded with a reminder of the firm’s ongoing responsibility to ensure compliance with all applicable regulations.