Drugs

CGMP Violations at Accu Bio-Chem Lab

An 8/24-8/31/21 FDA inspection at Accu Bio-Chem Laboratories, a Glendale, CA, contract testing laboratory, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 2/24 Warning Letter says specific violations were:

failing 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;
failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods; 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 reminds the lab that the agency considers contractors to be extensions of a manufacturer’s facility and the lab’s failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs it tests for its clients. FDA strongly recommended engaging a qualified consultant to assist the firm in meeting CGMP requirements.

Accu Bio-Chem was told to correct any violations promptly and to respond with a list of steps it has taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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