Drugs

CGMP Violations Seen at India’s Reliance Life Sciences

A 2/19-2/27 FDA inspection at the Reliance Life Sciences Private Limited drug manufacturing facility in Navi Mumbai, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/18 Warning Letter says the specific violations were:

failure to ensure that laboratory records include complete data derived from all tests necessary to ensure compliance with established specifications and standards; and
failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

The letter also says that significant inspection findings demonstrate that Reliance does not operate an effective quality system in accord with CGMP. FDA says it found that the firm’s quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities.

The agency acknowledges the firm’s commitment to suspend production of all drugs manufactured at the facility for the U.S. market. It placed all of the firm’s drugs and drug products offered for import into the U.S. on a 7/9 Import Alert.

Reliance was told to address the violations promptly and to respond within 15 days. FDA acknowledges the firm’s long-term commitment to meet CGMPs and its use of a third-party consultant to audit its operations and assist it in meeting CGMPs.

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