Drugs

FDA Releases Dr. Reddy's Establishment Report

FDA has released the Establishment Inspection Report from a 2/27-3/8/17 inspect at the Dr. Reddy’s manufacturing facility in Andhra Pradesh, India. The report says the facility continues to manufacture sterile injectable and tablet products for the U.S. market.

At the end of the inspection, FDA issued a 13-item FDA-483, the report says, including observations for: investigations into discrepancies that were not thorough, inadequate procedures for the qualification of visual inspection operators, failing to maintain and evaluate complete data, production records do not contain complete and accurate information, procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed, aseptic processing areas are deficient regarding the system for monitoring environmental conditions, procedures for the preparation of master production and control records are not followed, appropriate controls are not exercised over computer or related systems, data is not documented contemporaneously, thorough review of documents is not performed, procedures for maintenance of equipment had not been established and followed, samples taken for process validation are not scientifically justified, and samples collected to evaluate conformance of a batch are not representative.

In addition, FDA says, repeated instances of employees providing false or misleading statements were discussed with management.

“Firm management promised correction of all observations and committed to providing an initial written response within 15 business days,” the report concludes. “No samples were collected and there were no refusals. The facility has a current drug registration.”

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

Read more

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