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.

Beijing Taiyang Pharmaceutical Industry Co. Beijing, China (10/19): FDA attempted to inspect the firm 11/2015 and the firm limited the inspection. Agency investigators observed through a window a warehouse containing numerous drums. When investigators requested access to this warehouse, they were barred from entering until the following day when a significant number of drums had been removed and were not available for inspection. Investigators also documented that the firm’s methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to current good manufacturing practice. Additionally, investigators observed systemic data manipulation across the facility.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm527005.htm

Option Care Enterprises (Walgreens Infusion Services) Deerfield, IL (10/19). FDA inspected the firm 8/2015 and observed serious deficiencies in its practices for producing sterile drug products. For example, investigators observed poor personnel aseptic practices. Specifically, while performing aseptic operations, a technician leaned forward into the ISO 5 hood resting both elbows on the hood and covering the ventilation grid.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526853.htm

Wellcare Rx Investments LLC (dba Denson’s Specialty Pharmacy) Wheaton, IL (9/30): FDA inspected the firm 11/2015 and noted that the firm was not receiving valid prescriptions for individually-identified patients for a portion of the drug products it produced. In addition, the investigator observed serious deficiencies in practices for producing sterile drug products. For example, the investigator noted that the facility is not adequately designed for sterile drug production. Specifically, the laminar airflow hood, where aseptic production occurs, is located in an unclassified room that does not contain any HEPA filtration.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm526757.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