Drugs

CGMP Violations in 2 Unimark Facilities

FDA inspections at Unimark Remedies’ active pharmaceutical ingredient Vapi facility (5/18-5/22/15) and Belva facility (8/3-8/14/15), both in India, found significant deviations from current good manufacturing practice regulations, according to an 8/15 Warning Letter. Specific violations found at the Vapi facility included:

failing to adequately investigate and document out-of-specification results and to implement appropriate corrective actions; and
failing to evaluate the potential effect that changes in the manufacturing process may have on the quality of the firm’s active pharmaceutical ingredients.

Specific violations at the Belva facility included:

failing to adequately investigate and document out-of-specification results and to implement appropriate corrective actions;
failing to ensure that test procedures are scientifically sound and appropriate to ensure that the active pharmaceutical ingredients conform to established standards of quality and/or purity;
failing to maintain training records of employees involved in the manufacture of intermediates or active pharmaceutical ingredients; and
failing to properly keep buildings and facilities used in the manufacture of active pharmaceutical ingredients in a clean condition.

The company was told to respond with a list of the actions it took since the inspection to correct the deviations and prevent their recurrence, along with a timetable for completion.

At least eight other Warning Letters have been issued to firms in India in the first half of this calendar year.

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