Drugs

CGMP Violations at Hangzhou Sunking Nonwovens

An 8/7-8/9/18 FDA inspection at the Hangzhou Sunking Nonwovens drug manufacturing facility in Hangzhou, Zhejiang, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 1/29 Warning Letter says the specific violations were:

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;
failing to conduct at least one test to verify the identity of each component of a drug product and failing to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
failing to assure that the drug product bore an expiration date that was supported by appropriate stability testing;
failing to establish 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 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 letter reminds Hangzhou that it is responsible for the quality of the drugs it produces, regardless of agreements in place with contract facilities. It also says the company’s responses to the inspection observations did not provide sufficient details or evidence that the company will remediate its operations to ensure compliance with CGMP. Because of the nature of the violations found at the firm, FDA recommends that it retain a qualified consultant to assist it in meeting CGMP requirements if it resumes manufacturing drugs for the U.S. market. The company was placed on an import alert 12/13/18.

Hangzhou 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.

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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