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.

Acino Products, Hamilton, NJ (2/10): FDA inspected the company in 6/2019 and cited GMP violations for finished pharmaceuticals. For example, Acino failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair. The company also failed to clean, maintain, and sanitize or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination. To view the letter, click here.

Chemland, Gyeonggi-do, South Korea (2/11): FDA inspected the company in August and cited GMP violations for finished pharmaceuticals. For example, the company 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. Chemland also failed to establish written procedures for production and process controls. Additionally, it failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products. To view the letter, click here.

Jiangsu JDC Medical Devices Co., Jiangsu Sheng, China (12/19): FDA inspected the firm 9/2019 and cited GMP deficiencies with its Bulb Tip Yankauer and the Chemiluminated Vaginal Speculum. For example, the company failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements have been met. It also failed to develop, conduct, control, and monitor production processes. Additionally, Jiangsu failed to establish and maintain procedures to adequately control environmental conditions. To view the letter, click here.

Silfradent, Santa Sofia, Italy (10/28): FDA inspected the company in July 2019 and cited GMP violations with its SurgyBone device. For example, Silfradent failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met. Additionally, it failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. 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