Drugs

Quality, Data Issues in Pan Drugs Inspection

A 11/30-12/3/15 FDA inspection at Pan Drugs, Vadodara, India, found significant violations of current good manufacturing practice regulations and data integrity concerns in the firm’s manufacturing of finished pharmaceuticals, according to an 8/25 Warning Letter. Specific violations included:

failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process material, labeling, and drug products;
failing to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition and to keep them free of infestation by rodents, birds, insects, and other vermin;
failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements; and
failing to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records.

The letter says that the firm’s quality system “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” and acknowledges that the company has a consultant auditing its operation to assist in meeting FDA requirements.

Pan Drugs attempted to delay the start of the inspection, FDA says, and failed to provide some records that were requested.

The company was placed on an Import Alert 12/8/15. It was told to respond with a list of steps taken since the inspection to correct the violations and prevent their recurrence, along with a timetable for completion of corrective actions.

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