enforcement

Pharmaceutics International CGMP Violations

A 2/23-3/6 FDA inspection at Jabil Inc.’s Pharmaceutics International drug manufacturing facility in Cockeysville, MD, found significant violations of current good practice (CGMP) regulations for finished drugs. An 8/27 Warning Letter says the three specific violations were:

failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
failure to establish adequate written responsibilities and procedures applicable to the quality control unit; and
failure to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes, and failure to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair.

FDA says that significant findings in the letter demonstrate that the firm does not operate an effective quality system in accord with CGMP. “In addition to the lack of effective management oversight of your laboratory and production operations,” it says, “we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.” It recommends that the company engage a qualified consultant to evaluate its operations through a comprehensive six-system audit and assist it in meeting CGMP requirements. FDA also asks that the company meet with FDA in a teleconference to discuss the firm’s corrective and preventive actions in detail.

Jabil was told to correct the violations promptly and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

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