Tag Archives: fda 483

Innoveix Pharmaceuticals, Inc. Recall

Innoveix Pharmaceuticals, Inc. recently voluntarily recalled lots of sterile compounded drug products.  Semorelin/ Ipamorelin 3mg and injectable AOD-9604 3mg were the products that were recalled from specific Lots.  These products were not sterile—when intended to be sterile.  Having non-sterile products could lead to life-threatening infections.  These products were distributed nationwide to customers and medical facilities.…
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The Importance of Data Integrity

On January 15, 2021, GMP Trends posted Issue #1056.  In this issue, it states that the FDA found a Pharmaceutical manufacturer’s lab that was not recording data and other information properly for years.  For starters, the equipment calibration and logbook were not updated for 18 months, the possession of the drug products were not tracked…
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