Drugs

CGMP Violation at India’s Chemspec Chemicals

A 7/28-8/1/2025 FDA inspection at the Chemspec Chemicals Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India, found a significant deviation from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 12/23/2025 Warning Letter says the specific deviation was a failure of the firm’s quality control unit to exercise its responsibility to ensure the APIs and intermediates manufactured at the facility comply with CGMP.

The letter says the firm’s response to the inspection observation was inadequate. The agency notes that the Chemspec quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It strongly recommends that the company engage a qualified consultant to assist in its remediation.

FDA says a 2/5/2025 untitled letter referenced a similar deviation, and the company proposed remediations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of APIs are inadequate,” it says.

Chemspec was told to respond with a list of specific actions it has taken to address the deficiencies and prevent their recurrence, with a schedule for completing the corrections.

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