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FDA sends warning letter to KVK-Tech manufacturing facility

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Whats next for KVK-Tech?

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STAT+: Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show

STAT

In study documents, Mount Sinai doctors said the biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized.

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STAT+: Top FDA officials weighing regulation of ultra-processed foods, internal documents show

STAT

Two FDA officials, Haider Warraich and Robin McKinnon, met multiple times in February to discuss regulating these edible industrial creations, such as sodas, prepackaged cookies, and most breakfast cereals. Warraich serves as a senior adviser to FDA commissioner Robert Califf. Continue to STAT+ to read the full story…

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Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection

Fierce Pharma

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing reprimand from the FDA is alarming no matter which way you look at it. The FDA’s report cites six observations around poor quality control procedures, subpar cleaning, cross-contamination risks and more.

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STAT+: FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of key documents

STAT

Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana, India.

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Fixing pulse oximeters requires federal might and possible legal action, researchers say

STAT

  The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been approved between 1978-2024 and had accessible information about performance testing.

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FDA document outlines apparent agency support for full approval of Biogen, Eisai's Leqembi

Fierce Pharma

As Alzheimer's disease partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval. | As Alzheimer's partners Eisai and Biogen lay the groundwork for a wider launch of Leqembi, their efforts center on winning a full FDA approval.