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.

Lupin Ltd. Mumbai, India (11/6): FDA inspected the firm’s Goa and Indore drug manufacturing facilities in April and May and documented significant GMP violations with finished pharmaceuticals. At Goa, FDA says the firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications. It also failed to establish appropriate time limits for the completion of each phase of production to assure the quality of the drug product. At Indore, the firm failed to establish appropriate time limits for the completion of each phase of production to assure the quality of the drug product. And FDA recommended that the firm hire a GMP consultant to help bring its facilities into compliance.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm584699.htm

ProSun International Saint Petersburg, FL (10/25): FDA inspected the firm in August and found GMP violations with its sunlamp/tanning beds. For example, the firm failed to establish procedures for finished device acceptance. Also, the firm failed to establish corrective and preventive action procedures.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm584155.htm

RTI Surgical Alachua, FL (11/8): FDA inspected the firm in April and determined that its bone graft product does not have of an approved BLA or IND in effect. The agency also documented evidence of significant GMP deviations that raises potential safety concerns. For example, FDA says RTI’s unvalidated processes and inadequately controlled environment pose a product contamination risk. Additionally, the firm failed to establish written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm585041.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