Drugs

CGMP Violations at Deqing Jiarou

FDA says its review of records submitted by Deqing Jiarou Daily Chemical Co., Ltd., in Huzhou, Zhejiang, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/18 Warning Letter says the specific violations were:

failing to conduct at least one test to verify the identity of each component of a drug product;
failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product;
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products; and
failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products.

The agency recommends that Deqing retain a qualified consultant to assist it in meeting CGMP requirements. It placed the company on an Import Alert on 2/13.

Deqing was told to correct violations promptly and to respond with a list of specific actions it has taken to address violations and prevent their recurrence, with a schedule for completing the corrections.

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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