Drugs

CGMP, Labeling Violations at Korea’s Seindni Company

A 5/25-5/26 FDA inspection at Seindni Co., Seoul, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 12/5 Warning Letter. The letter says the agency investigators found that the company failed to establish a quality control unit and procedures applicable to the 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, including drug products manufactured, processed, packed, or held under contract by another company.

According to FDA, Seindni uses contract manufacturers to produce its over-the-counter drug products distributed in the U.S. and confirmed that the contract manufacturers do not make the products in conformance with drug CGMP.

The firm was told to respond with written procedures establishing an adequate quality control unit with the authority to carry out its responsibilities.

FDA recommended that Seindni engage a qualified consultant to assist it in meeting CGMP requirements.

Investigators also found that labeling of the company’s sunscreen and skin protectant OTC drug products does not comply with applicable regulations.

The firm was placed on Import Alert 8/23.

Seindni was told to respond with a list of actions 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

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

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