FDA Policy/General

Latest FDA Warning Letters

Recently FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Guangzhou Haishi Biological Technology Co., Ltd. Guangzhou, Guangdong China (6/22). Inspected 7/20-24/15. GMP deviations, adulterated: The firm failed to test finished batches of the firm’s drug products for the identity and strength of active ingredients. It failed to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality, and purity they purport or are represented to possess. It also failed to failed to conduct at least one specific identity test on a component when relying on that component supplier’s analysis, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.165(a), 211.84(d)(2), 211.100(a)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm508876.htm

Zimmer Biomet Holding, Inc. Warsaw, TN (5/27). Inspected Montreal, Quebec, Canada facility 1/25-28. QSR deviations, adulterated: The firm failed to establish and maintain procedures for implementing corrective and preventive action. The procedure does not describe how data will be analyzed to detect recurring quality problems; what sources of quality data are required for analysis, and does not require using appropriate statistical methodology where necessary to detect recurring quality problems. Eight out of 14 complaints reviewed by the investigator for FY15 did not include a Medical Device Reporting (MDR) determination. Also, the firm’s procedure does not include requirements to ensure complaints are evaluated in a timely manner to ensure that MDR reportability timeframes are met, etc. (iAssist Knee System, Zimmer PSI Shoulder System, Zimmer PSI Knee System, and the Navitrack System); FDCA 502(t)(2), 21 CFR 501(h), 21 CFR 820.100(a), 820.198(a), 820.50, 820.181, 820.72(a), 820.22, 803.17, 806.10, 806.20
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm508895.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