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.

Eagle Pharmacy, Inc. Hoover, AL (10/13). FDA investigator inspected the firm’s drug compounding operations 8/2015 and documented serious deficiencies in its practices for producing sterile drug products. For example, the investigator observed an operator moving their arm over open vials during aseptic filling. In addition, the investigator observed an operator transferring materials onto the critical work surface without first disinfecting the materials. Additionally, the investigator also noted that media plates used for personnel and environmental monitoring did not contain disinfectant neutralizers, which could potentially bias results.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525126.htm

SaveWay Compounding Pharmacy, Inc. Newark, DE (10/4). An FDA investigator inspected the drug compounding facility 8/2015 and noted that the firm was not not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced. The investigator also noted records showing that the firm produced domperidone drug products, which are not the subject of a recognized drug monograph. In addition, the investigator observed serious deficiencies in its practices for producing sterile drug products, which put patients at risk.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525104.htm

U.S. Specialty Formulations Bethlehem, PA (9/30). FDA investigators inspected firm’s facility in 5/2015 and documented that it did not have an adequate contact time for a sporicidal agent used to disinfect aseptic processing areas. In addition, the firm’s environmental program did not include personnel monitoring sampling, and operators donned their gowning in an unclassified office area.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525103.htm

University Rx Specialties Inc. (dba University Compounding Pharmacy) San Diego, CA (9/28). An FDA investigator inspected firm’s drug compounding operations in 8/2015 and noted that it was not receiving valid prescriptions for individually-identified patients for a portion of the drug products produced. In addition, the investigator observed serious deficiencies in firm’s practices for producing sterile drug products. For example, the firm failed to use sterile wipes and used a non-sterile disinfectant as part of the disinfection program for the aseptic processing areas.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm524851.htm

Vetix, Inc. Lexington, KY (10/12). FDA inspected animal drug manufacturing facility in May and documented the firm’s production of unapproved animal drugs. In addition, an FDA laboratory analysis of samples of products collected during the inspection confirmed the presence of microbial growth in your OptiMend, OptiVet, and Hy-Optic products, which are purported to be sterile. The firm subsequently notified the agency that it has discontinued manufacturing and distributing the products.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm525191.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