Drugs

FDA Cites Documentation Lapses at Maiva Pharma

FDA investigators have cited manufacturing and documentation issues at an Indian sterile drug facility operated by Maiva Pharma Private Ltd. following an inspection last month, according to an inspection report issued by the agency. The inspection, conducted from 2/10-20 at the company’s plant in Hosur in the Indian state of Tamil Nadu, resulted in a Form 483 citing deficiencies in production documentation and record control at the sterile drug manufacturing site.

According to the FDA investigators, production records at the facility “do not contain complete information relating to the production and control of each batch.” During an initial walkthrough on 2/10, inspectors reported finding numerous original current good manufacturing practice (CGMP) documents discarded in trash bags in a scrap area of the plant.

The discarded materials were associated with the manufacture of drugs intended for the U.S. market and were not marked as copies, voided under an approved procedure, or otherwise reconciled through the company’s document control system, investigators said.

Among the items found in the trash were environmental monitoring records written on gloves, in-process equipment reports, weighing verification printouts, sterilization records documenting aseptic interventions, fill-volume weighing reports, and raw-material dispensing printouts tied to commercial and exhibit batches. Some records had been torn into multiple pieces, the agency noted.

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