Drugs

FDA Hits India Drug Maker with 14-page 483

A recent inspection of Global Pharma Healthcare in Tamilnadu, India has led to a just-posted 14-page FDA Form-483 that cites significant GMP deficiencies. For example, the form says the company’s procedures for preventing microbiological contamination were inadequate because they did not include validation of the sterilization process. Presumably, the inspection came about in reaction to several recalls involvng contaminated artificial tear drop products and a subsequent import alert involving the company (see story).

The 2/20-3/2 inspection also cited the firm over its test methods. For example, it said the sterility method suitability testing for two ointment products did not meet “protocol acceptance criteria.” It also said the equipment used was not appropriate for its intended use.

Additionally, FDA said aseptic processing areas are deficient because the system for cleaning/disinfecting the room was not adequate. And the agency said the company failed to verify the identity of each component of a drug product, and it failed to validate the reliability of its component supplier’s test analyses at appropriate intervals.

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