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As onsite pharma FDA inspections resume in earnest, the agency will use state advisory level rating
As the COVID-19 pandemic continues and in-person activities and travel remain restricted, FDA has been
Health authorities rely on inspections of pharma manufacturing facilities as a critical element of the drug
FDA recently posted a 38-page form 483 issued to Novel Laboratories, Inc d.b.a.
December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec.
The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter
A comprehensive GMP intelligence program includes monitoring health authority enforcement actions.
In response to the 2012 fungal meningitis outbreak that occurred at the New England Compounding Center
In recent years, significant data integrity lapses have occurred at global pharmaceutical, biotechnology,