Drugs

CGMP Violations at India’s Rxhomeo

A 1/28-2/1 FDA inspection at Rxhomeo Private Limited, Hyderabad, Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 6/13 Warning Letter says the violations were:

failing to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failing to validate and establish the reliability of component suppliers’ test analyses at appropriate intervals;
failing to prepare batch production and control records with complete information relating to production and control of each batch of drug product produced; and
failure of the firm’s quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The agency recommends the firm retain a qualified consultant to assist it in meeting CGMP requirements as well as performing a comprehensive audit of Rxhomeo’s entire operation for CGMP compliance and the completion and efficacy of the firm’s corrective and preventive actions.

Rxhomeo was placed on an FDA import alert 5/22.

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