Drugs

Antaria API Deviations Cited

An 11/13-11/17/2023 FDA inspection at the Antaria Pty. Ltd. drug manufacturing facility in Queensland, Australia, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 3/22 Warning Letter says specific deviations were:

failure to adequately investigate and document out-of-specification results and implement appropriate corrective actions;
failure to ensure that, for each batch of API, appropriate laboratory tests are conducted to determine conformance to specifications;
failure to have laboratory control records that include complete data derived from all laboratory tests conducted to ensure that API complies with established specifications and standards; and
failure to design an adequate, documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.

The letter says the firm’s responses to the inspection observations were inadequate. FDA said Antaria should correct deviations promptly and respond with a list of specific steps it has taken to address any deviations and prevent their recurrence, with a schedule for completing the corrections.

Gupta Raises Concerns About Overton’s Independence, Ideology

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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