Drugs

Dr. Reddy’s Hit with 7-Item FDA-483

FDA has posted a seven-item Form FDA-483 after inspecting Dr. Reddy’s Mirfield, West Yorkshire, UK, active pharmaceutical ingredient (API) manufacturing facility 9/1-5/2025. The key GMP deficiencies noted were:

Failure to establish adequate specifications, sampling plans, and testing procedures to ensure that raw material and APIs meet accepted quality standards and are consistent with the manufacturing process.
Certificates of analysis from raw material suppliers are accepted in lieu of testing each component for conformance to written specifications.
Failure to adequately validate written procedures for the cleaning and maintenance of equipment.
Written records of investigations into unexplained discrepancies do not always include the conclusion and follow-up.
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Document control procedures under quality unit oversight are inadequate.
Manually managed materials in the warehouse and facilities are not separated during storage.

This is the second Dr. Reddy’s 483 released this month by FDA. The agency issued a five-item Form FDA-483 after inspecting the firm’s drug substance and drug product manufacturing facility last month in Telangana, India (see story).

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