Drugs

14 Observations in Meridian Medical Inspection

FDA has released the FDA-483 issued following a 2/20-3/24 inspection at Pfizer’s Meridian Medical Technologies combination drug/device manufacturer, whose products include the EpiPen, in Brentwood, MO. The 14 inspection observations were:

failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failing to establish control procedures that monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product;
failing to establish, write down, and follow procedures describing the handling of all written and oral complaints about a drug product;
failing to adequately establish procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics;
failing to maintain records so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures;
failing to adequately establish procedures for design input;
failing to adequately establish procedures for design validation;
failing to have laboratory controls include establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
failing to give the quality control unit the responsibility and authority to approve and reject all components, drug product containers, in-process materials, packaging material, and drug products;
failing to establish and follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
failing to follow written production and process control procedures in the execution of production and process control functions and to document them at the time of performance; and
failing to provide adequate training to employees engaged in the manufacture, processing, packing, and holding of a drug product so they can perform their assigned functions.

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