Drugs

CGMP Violations at Turkey’s Gulsah Uretim Kozmetik

FDA says its review of requested records supplied by Gulsah Uretim Kozmetik Sanayi Anonim Sirketi, Istanbul, Turkey, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 5/13 Warning Letter says 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 before 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 firm’s component supplier’s test analyses at appropriate intervals; and
failing to establish and follow an adequate written testing program to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates.

FDA says the firm’s quality systems are inadequate and recommends that it retain a qualified consultant to conduct a comprehensive audit of its entire operation for CGMP compliance, assist the firm in meeting CGMP requirements, and evaluate the completion and efficacy of the firm’s corrective actions.

The company’s products were placed on an FDA import alert 3/29. Gulsah was told to respond with a list of steps it has taken to correct the violations and prevent their recurrence with a schedule for completing the corrections.

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

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

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