FDA Policy/General

Latest FDA Warning Letters

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Lupin Limited, Madhya Pradesh, India (9/10): FDA inspected the firm 12/2018 and cited significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients (API). For example, Lupin failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. The company also failed to establish adequate written procedures for production and process controls. And it failed to clean, maintain, and sanitize and sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination. FDA said similar GMP violations were found at two other facilities in Lupin’s manufacturing network. To view the letter, click here.

Shanghai Institute of Pharmaceutical Industry, Shanghai Shi, China (8/29): The contract testing lab refused a pre-announced inspection in a written response to FDA’s China Office 12/4/2018. The firm provides active pharmaceutical ingredient (API) characterization and identification testing to support multiple ANDAs. FDA told the firm that drugs it has tested are deemed adulterated if they refuse an inspection. To view the letter, click here.

Dermameal, Gyeonggi-do, South Korea (9/12): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed 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. Dermameal also failed to establish and follow adequate written responsibilities and procedures applicable to the quality control unit. Additionally, it failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use the results to determine appropriate storage conditions and expiration dates. To view the letter, click here.

Galt Pharmaceuticals, Atlanta, GA (9/13): FDA reviewed a company email distribution to health professionals on insomnia drug Doral (quazepam) tablets and cited it because it made misleading claims and representations about the drug’s risks. The letter charged that the Doral email included numerous claims and presentations about the drug’s benefits, but it completely omitted warnings and precautions about benzodiazepine withdrawal syndrome. To view the letter, click here.

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