Drugs

CGMP Violations at Hangzhou Guoguang Touring Commodity

A 4/17-4/20/18 FDA inspection at Hangzhou Guoguang Touring Commodity Co., Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A just-released 12/14/18 Warning Letter says specific violations were:

failing to establish and follow adequate written procedures for cleaning and maintenance of equipment;

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;

failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release, and failing to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms; and

failing to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

The letter says that if the firm resumes manufacturing drugs for the U.S. market, FDA strongly recommends that it engage a qualified consultant to assist it in meeting CGMP requirements. The agency also reminds the firm of the duties of contractors that are considered to be extensions of the manufacturer. “You are responsible for the quality of drugs you produce as a contract facility,” it says. “You are required to ensure that drugs are made in accordance with [legal requirements] for safety, identity, strength, quality, and purity.”

Hangzhou Guoguang was placed on an import alert 10/5/18.

The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a timetable for completion of the actions.

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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