Drugs

Intas Pharma on Import Alert After Inspection

FDA has placed an import alert on drug products manufactured by Intas Pharmaceuticals in Ahmedabad, Gujarat, India due to significant GMP violations documented in a 12/2022 inspection of the facility. According to an FDA letter referencing the import alert, 25 medically necessary products made by the company are being excluded from the alert as long as certain conditions are met. For example, medically necessary products will need to go through batch certification by an independent third-party “confirming that the referenced batches meet the quality attributes and have not been associated with data integrity practices or unresolved [out-of-specification] OOS events,” according to the letter.

An FDA-posted Form FDA-483 issued following the inspection cited 11 observations. They were:

laboratory records do not include complete data derived from all tests, examinations, and assays necessary to assure compliance with established specifications and standards;
failing to follow established test procedures and laboratory control mechanisms;
failing to fully follow the responsibilities and procedures applicable to the quality control unit;
failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
failing to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
results of stability testing are not used in determining stated items;
failing to extend investigations of a failure of a batch or any of its components to meet any of its specifications to other drug products that may have been associated with the specific failure or discrepancy;
failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed;
failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel; and
failing to establish the accuracy, sensitivity, and reproducibility of test methods.

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