Drugs

Multiple Violations at Nan San Pharmaceutical

A 9/25-9/29/17 FDA inspection at Nan San Pharmaceutical Factory, Hong Kong, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, along with other violations, according to a 2/23 Warning Letter. Specific violations cited in the letter 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 for each batch of drug product required to be free of objectionable microorganisms, appropriate laboratory testing as necessary;
failing to establish written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess;
failing to conduct at least one test to verify the identity of each component of a drug product; and
failing to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of the stability testing to determine appropriate storage conditions and expiration dates.

FDA says it recommends that the firm engage a qualified consultant to assist it in meeting CGMP requirements. The letter also identifies misbranding violations for the firm’s Musflex and Easy-Flex because their labels fail to declare active ingredients, the proportion of each active ingredient, and inactive ingredients. The products also are misbranded because the labeling fails to bear required warnings, the letter says.

The firm was placed on an import alert 1/8. 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.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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