Biologics

HCT/Ps Violations at 2 Banco Vida Facilities

A 9/9-9/18/19 FDA inspection at Banco Vida Corp and Laboratorio Banco Vida, San Juan, Puerto Rico, determined that the firm manufactures human umbilical cord blood for allogenic use and that it recovers umbilical cord blood and processes an umbilical cord blood product in its facility. An 8/12 Warning Letter says the firm distributes its cord blood intermediates for further manufacturing into an allogenic umbilical cord blood-derived product intended for injection and purported to be sterile.

The agency says it considers such umbilical cord blood and cord blood intermediates as human cells, tissues, or cellular or tissue-based products that are regulated as drugs and biological products and do not possess a valid BLA or IND.

The inspection also documented evidence of significant deviations from current good manufacturing practice and current good tissue practice regulations, the letter says. “Then deviations in manufacturing observed as well as those noted in documents collected during the inspections indicate that the use of your products raises potential significant safety concerns,” the letter says. Specific area of concern were:

failing to screen a donor of cells or tissue by reviewing the donor’s relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases;
failing to adequately establish and follow written procedures designed to prevent microbiological contamination of its cord blood intermediate used to manufacture drug products purporting to be sterile;
failing to establish written procedures for production and process control designed to assure that the cord blood intermediates have the identity, strength, quality, and purity they purport or are represented to possess;
failing to establish and follow adequate written procedures for cleaning and maintaining the equipment used in the manufacture, processing, packing, or holding of cord blood intermediates;
failing to conduct environmental and personnel monitoring during the manufacturing of cord blood intermediates that are subject to contamination; and
failing to accurately document in batch production and control records incoming umbilical cord blood temperature controls.

FDA acknowledges the firm’s commitment to cease manufacturing cord blood intermediates at Laboratorio Banco Vida but says the firm’s responses to the inspection observations either do not address the stated violations or are inadequate to correct the violations.

Banco Vida was told to take prompt action to correct the violations and to respond with specific steps taken or planned to correct the violations and prevent their recurrence, with any documentation necessary to show that correction has been achieved and a schedule for completion of the steps.

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