FDA Policy/General

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.

Denttio, Inc. Los Angeles, CA (2/23): FDA inspected the firm 8/2016 and documented GMP deficiencies related to its manufacture of digital x-ray image receptors and intraoral microscope/cameras. For example, FDA said the firm failed to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. The firm also failed to establish procedures for corrective and preventive action. Additionally, FDA cited it for failing to perform device software validation and risk analysis.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm543694.htm

Megafine Pharma Ltd. Mumbai, India (2/24): FDA inspected the firm 9/2016 and documented significant drug GMP deviations. For example, FDA cited the firm’s quality unit for using sourced material from a facility on an agency Import Alert. The inspection also found that interior surfaces of its drug manufacturing equipment were not clean as required by procedures.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm544066.htm

Morton Grove Pharmaceuticals Morton Grove, IL (2/17): FDA inspected the firm 2/2016 and documented significant GMP violations for finished pharmaceuticals. FDA investigators documented that the firm’s investigations into out-of-specification test results were not thorough, timely, or based on scientific rationales. The firm also was cited for multiple batches of fluticasone propionate nasal spray failed their release criteria that were explained as analyst error without proper scientific justification. In addition, the inspection revealed that the firm failed to submit field alert reports.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm545133.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