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.

Morton Drug Company (dba Morton Long Term Care) Neenah, WI (10/26): FDA investigators inspected the facility 12/2015 and observed serious deficiencies in the firm’s practices for producing sterile drug products. For example, investigators observed that the firm did not monitor pressure differentials between what you refer to as the “clean room” and “ante room.” Furthermore, they observed operators cleaning the ISO 5 hood with non-sterile cleaning agents while wearing street clothing, and having uncovered arms, exposed facial skin, neck skin, and hair while under the interior of the hood.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm528190.htm

Sekisui Medical Co. Nihombashi, Tokyo, Japan (11/8): FDA inspected the firm’s Matsuo, Hachimantai, Iwate facility in June and observed significant deviations from current good manufacturing practice for active pharmaceutical ingredients. The inspection found that the firm failed to maintain complete data from all laboratory analyses, and that it relied on the incomplete information to determine whether drugs met established specifications. It also cited the firm’s laboratory systems for lacking controls to prevent deletion of and alterations to electronic raw data. Additionally, an analyst demonstrated that he could change the data, including injection time and date, without the changes being captured in the audit trail, prior to printing the results.
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm528590.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