Drugs

Panacea Biotec Gets 9-item FDA-483

FDA has issued Panacea Biotec Pharma a nine-item Form FDA-483 after inspecting the firm’s Himachal Pradesh, India manufacturing 10/3-12 and documenting GMP deficiencies. The company says that the inspection’s findings are “related to improvements in existing procedures and are addressable.”

According to the FDA-483, agency investigators took issue with the following:

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Manufacturing employees lack the training required to perform their assigned functions.
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
Failure to thoroughly review any unexplained discrepancy and failure of any batch or components to meet the specifications.
Procedures for cleaning and maintenance are deficient regarding sufficient detail of the methods, equipment and materials used in the cleaning and maintenance operation.
Laboratory controls did not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling and drug products conform to appropriate standards.
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Equipment used in manufacturing, processing, packing or holding is not of appropriate design and suitability to facilitate operations for its intended use.

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