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Medical Devices / Inspections and Audits

Quality Control Procedures Lacking at Wellman Advanced Materials

March 11, 2019

Written procedures were found to be missing for a range of quality parameters at Wellman Advanced Materials’ Johnsonville, SC, plant during a Dec. 10 to Dec. 13, 2018 FDA inspection.

The compounder of thermoplastic resins lacked written procedures for its quality unit or records of annual evaluations or reviews for FDA-regulated products.

“GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with GMP requirements,” the agency said. Records indicated that GMP training had not been conducted since 2014 and there was no documented training for laboratory personnel.