Drugs

Quality, Data Integrity Issues Flagged at Indian API Maker Hikal

FDA has cited significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the company’s active pharmaceutical ingredient (API) facility in Jigani, near Bengaluru, India. According to a Form FDA-483 issued at the close of the inspection, investigators documented six major observations, including recurring contamination complaints, inadequate handling of out-of-specification (OOS) results, and weaknesses in computerized data controls.

FDA investigators reported that foreign matter contamination — including metal particles, fibers, and other debris — has been repeatedly identified in products by customers since the agency’s previous inspection in 2019. The continued stream of complaints suggests systemic failures in contamination control, particularly in preventing metal and particulate intrusion during manufacturing, according to the agency.

FDA also raised concerns about the company’s handling of OOS results. Of 92 invalidated OOS results associated with U.S.-distributed products, 24 were dismissed without a scientifically justified root cause. In those cases, the firm relied on passing retest results to release batches, a practice regulators have repeatedly warned can mask underlying quality issues.

Additionally, the agency said serious data integrity concerns were also identified. Investigators discovered that backup laboratory data — including chromatographic records — were stored in unsecured folders without access controls, making them vulnerable to deletion or manipulation. During the inspection, an FDA investigator was able to access and nearly deleted files while logged in under a managerial account. The firm’s IT personnel were also reportedly unaware that critical backup data was being stored outside designated secure systems.

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