Drugs

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.

Biomedix, Bloomington, IN (2/12): FDA inspected the firm 10/2019 and cited GMP violations with its medical device operations. For example, the company failed to establish and maintain procedures to control products that do not conform to specified requirements, including a determination of the need for an investigation and documentation of that investigation. Biomedix also failed to validate a process whose results cannot be fully verified by subsequent inspection and tests. To view the letter, click here.

JHS Svendgaard Hygiene Products, Pradesh, India (2/13): FDA inspected the company 8/2019 and cited significant GMP violations for finished pharmaceuticals. For example, JHS failed to validate and establish the reliability of its component supplier’s test analyses at appropriate intervals. The company also failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. To view the letter, click here.

KVK-Tech, Newtown, PA (2/11): FDA inspected the company 4/2019 and cited significant GMP violations for finished pharmaceuticals. For example, KVK failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. It also failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. Additionally, the company failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records. To view the letter, click here.

Unetixs Vascular, North Kingstown, RI (2/4): FDA inspected the company 10/2019 and cited GMP deficiencies with its vascular diagnostic ultrasound systems. For example, Unetixs failed to establish and maintain procedures for design controls to ensure that specified design requirements are met. The company also failed to develop, conduct, control, and monitor production processes to ensure that the device conforms to its specifications. To view the letter, click here.

Yibin Lihao Bio-technical, China (2/13): FDA inspected the company 8/2019 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the company failed to prepare and use production and control records for each intermediate and batch. Additionally, the company failed to establish, document, and implement an effective system for managing quality that involves the active participation of management and appropriate manufacturing personnel. 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