Drugs

Shriram Institute FDA Inspection Found CGMP Issues

A 10/15-10/22/19 FDA inspection at Shriram Institute for Industrial Research, Delhi, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API) in its work as a contract testing laboratory. A 4/15 Warning Letter lists the violations and deviations as:

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;
failing to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow such written procedures; and
failing to ensure that all test procedures are scientifically sound and appropriate to ensure that raw materials and API conform to established standards of quality and/or purity.

The letter notes that an 8/2-8/5/16 inspection cited similar CGMP violations and the firm had proposed specific remediations for those observations. “Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate,” it says.

FDA strongly recommended that the firm retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It also recommended a consultant to address data integrity issues and asked for (1) a comprehensive investigation into the extent of the inaccuracies in data records and reporting; (2) a current risk assessment of the potential effects of the observed failures on the quality of drugs tested for commercial release, and (3) a management strategy for the firm that includes details of its global corrective and preventive action plan.

Shriram was told to respond with a list of specific steps taken since the inspection to correct the violations and deviations and prevent their recurrence, with a timetable for completing 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