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.

Hangzhou Zhongbo Industrial Co., Zhejiang, China (11/27/2018): FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. The company failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications. It also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of its drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates. FDA said the firm’s quality unit is not able to fully exercise its authority and responsibilities, and it recommended that a consultant be retained to assist it in achieving GMP compliance.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630081.htm

Longbow First Aid Products Manufactory Foshan, China (12/14/2019) FDA inspected the firm 4/2018 and cited significant GMP violations for finished pharmaceuticals. For example, Longbow does not have, for each batch of drug product purporting to be sterile, an appropriate laboratory determination of satisfactory conformance to final specifications. The company also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630718.htm

Lymol Medical Woburn, MA (1/8): FDA has determined that the firm failed to comply with a milestone date for completing a postmarketing requirement (PMR) for its NDA for sterile talc powder. Failure to comply with PMR milestone dates without demonstrating good cause renders the product misbranded. FDA says the violation is concerning from a public health perspective because the agency is aware of lead content in sterile talc, and failure to conduct the PMR impedes the evaluation of neurological, reproductive, developmental, immune, cardiovascular, and renal toxicities from lead exposure through use of the product.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm630182.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