Drugs

CGMP Violations at Sunstar Guangzhou

A 6/24-6/28/19 FDA inspection at Sunstar Guangzhou, Guangdong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/22 Warning Letter says specific violations were:

failing to perform, 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 to conduct appropriate laboratory testing for each batch of drug product required to be free of objectionable microorganisms;
failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality;
failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that all components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity; and
failing to establish an adequate quality control unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

The letter says the firm’s response was inadequate in that it did not provide sufficient detail or evidence of corrective actions to bring the operation into compliance with CGMP. FDA recommends that the company retain a qualified consultant to assist it in meeting CGMP requirements.

The agency also expresses concern over the use of glycerin as an ingredient in the company’s drug products, noting that the use of glycerin contaminated with diethylene glycol has resulted in various lethal poisoning incidents in humans worldwide.

Sunstar was placed on import alert on 1/21. It was told to respond with a list of specific actions 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

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome