Drugs

Inspection Finds CGMP Issue at Sanit Technologies

A 3/1-3/5 FDA inspection at Sanit Technologies (Durisan), Sarasota, FL, a drug manufacturing facility, found current good manufacturing practice (CGMP) regulation violations for finished drugs. A 7/27 Warning Letter says the specific violation was:

the firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength quality, and purity.

The letter also cites concern about Burkholderia cepacia complex in non-sterile, water-based drug products.

FDA acknowledges the company's decision to cease all production and distribution of drug products from the site as of 6/30. The letter says remediating the CGMP violations will be necessary if Sanit, a successor, or an acquirer resumes drug manufacturing operations at the site for the U.S. market.

Sanit 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 work.

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