Drugs

Immunomedics FDA-483 Has 13 Observations

FDA has released the FDA-483 with 13 observations issued following an 8/6-8/14/18 inspection at Immunomedics, a Morris Plains, NJ, drug substance intermediate manufacturing facility. Specific observations were:

the quality unit lacks authority to investigate critical deviations of approved procedures, specifically involving a 2/2018 data integrity breach that did not trigger a deviation;
there is no assurance that samples and batch records from the process validation and commercial batches manufactured before 2/2018 were not affected by the data integrity breach;
retesting procedure for a redacted item is inadequate;
the raw material sampling and testing program is inadequate;
the firm lacks procedures for inventory audit trail and reconciliation of raw materials used to manufacture a redacted item;
differential pressure between GMP areas of different area classification is not adequately maintained and monitored;
design of the facility is inadequate in that no drains are present in specified rooms and there is no standard operating procedure for liquid containment and disposal after a catastrophic spill;
there is no signed quality agreement between Immunomedics and a redacted firm that supplies cell culture media and all buffers, solutions, and chromatography resins used for redacted items;
no procedure is in place for redacted trending of results;
deviation investigations and corrective and preventive action implementations are inadequate;
deviation initiation and closing times are inadequate;
cleaning of redacted equipment is not validated or verified; and
the procedure to prevent contamination of a redacted item under specified circumstances is inadequate for specified conditions.

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