Drugs

Dong Yuan Technology CGMP Violations

A 9/24-9/28/18 FDA inspection at Dong Yuan Technology Co., Shandong Province, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/18 Warning Letter says specific violations were:

failing to establish and follow laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to establish adequate written procedures for production and process control designed to assure that the drug products the firm manufactures have the identity, strength, quality, and purity they purport or are represented to possess; and
.failing to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.

“Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the letter says. It recommends that the firm retain a qualified consultant to assist it in remediation. Dong Yuan was told to provide (1) a comprehensive investigation into the extent of data record inaccuracies and reporting including results of the data review for drugs distributed in the U.S.; (2) a current risk assessment of the potential effects of the observed failures on the quality of the firm’s drugs; and (3) a management strategy including details of a global corrective and preventive action plan.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome