FDA Policy/General

Latest FDA Warning Letters

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

Divi’s Laboratories Ltd. Andhra Pradesh, India (4/13): FDA inspected the firm in December and found significant GMP deviations for active pharmaceutical ingredients (APIs). The agency says the firm limited the inspection’s access to certain records, which automatically makes its products adulterated. The letter also says the firm failed to ensure that test procedures are scientifically sound and appropriate to ensure that its APIs conform to established standards of quality or purity. Additionally, the inspection discovered a lack of basic laboratory controls to prevent changes to and deletions from electronically-stored data in laboratories.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554576.htm

Exact-Rx, Melville, NY (4/19): FDA reviewed the firm’s listing information for its Sulfacetamide and Sulfur 10%/5% Cleanser product and determined the listing information is inaccurate. The review found that the active ingredient, sulfur, is missing from the structured product labeling listing information. The active ingredient Ferrous Cation is instead included, which does not match the list of active ingredients included in the product’s labeling.
https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554253.htm

Teva Pharmaceutical and Chemical Hangzhou, Zhejiang, China (4/5): FDA inspected the firm 9/2016 and cited it for significant GMP deviations involving its active pharmaceutical ingredients (APIs). For example, the firm failed to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of its APIs. The agency says that about 10% of undisclosed API batches failed to meet an impurity limit. Additionally, Teva failed to establish a sampling plan based on scientifically-sound sampling practices.

https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm554461.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