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.

Kalchem International, Lindsay, OK (8/27): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients (APIs). For example, Kalchem failed to have, for each batch of a drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient. The firm’s quality unit also failed to exercise its responsibility to ensure the APIs manufactured at the facility comply with GMPs. To view the letter, click here.

Mayon’s Pharmaceuticals, Maharashtra, India (9/4): FDA inspected the firm in February and found significant GMP violations for finished pharmaceuticals. For example, Mayon’s failed to establish written procedures for production and process controls designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess. It also failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and its cleaning and maintenance. To view the letter, click here.

Silkprousa, Miami, FL (8/18): FDA says the firm is marketing its Pink Luminous Breast, a Class 3 transilluminator for breast evaluation, without marketing approval. The agency says the determination was based on the labeling on the package, statements on the company’s Web site and how the device functions, such as visualizing translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities. The device was also found to be misbranded because labeling on the product’s package and Web site uses FDA’s logo. 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