Drugs

CGMP Issues at Kalchem

A 2/10-2/21 FDA inspection at Kalchem International, Lindsay, OK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients (API). An 8/27 Warning Letter says specific issues were:

failing to have, for each batch of a drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, before release; and
failure of the firm’s quality unit to exercise its responsibility to ensure the API manufactured at the facility comply with CGMP.

The letter also details API misbranding violations and unapproved new drug and misbranding violations. It notes that an 11/2017 inspection cited the firm for not having appropriate procedures in place for its operations. The firm proposed specific remediation for the inspection observations at that time and FDA says that “repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.”

The agency says that because of the nature of the violations and deviations identified at the firm and because repeat deviations were not repeated, it strongly recommends that Kalchem engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements.

The company was told to respond with a list of specific steps taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the 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