Drugs

Latest FDA Warning Letters

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

Badrivishal Chemicals & Pharmaceuticals Maharashtra, India (3/2): FDA inspected the firm 8/2016 and cited significant GMP deviations for manufactured active pharmaceutical ingredients (API). For example, FDA investigators found that the firm’s water purification system was not adequately monitored and controlled. Additionally, the inspection cited the quality unit over documents related to the API manufacturing. Investigators found a large number of trash bags behind a building that contained torn original laboratory and production records, such as analytical test reports, water testing reports, and sample notebooks. The information on these discarded, torn documents did not match the official records.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545454.htm

Lumis Global Pharmaceuticals Co. Wuhan, Hubei, China (3/2): FDA inspected the firm 9/2016 and cited GMP deviations related to active pharmaceutical ingredient (API) manufacturing. For example, the firm failed to transfer all quality or regulatory information received from the API manufacturer to certificates of analysis it issued to customers. The inspection also cited the firm for failing to control the API repackaging, relabeling, and holding operations in order to avoid mix ups and loss of API identity. Additionally, the firm was cited for shipping drugs from a manufacturer on FDA import alert.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545464.htm

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