The FDA found concerns at a factory in India that makes generic drugs for U.S. patients including one drug that was manufactured at the facility and has been linked to at least eight deaths, ...
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The Difference Between FDA And USDA Food Regulations, ExplainedWe've all seen the various inspection labels at the grocery store and heard news about food recalls. But what's the actual ...
Drug firm Alembic Pharmaceuticals Ltd on Friday (March 7) announced the completion of a scheduled inspection by the United States Food and Drug Administration (FDA) at its bioequivalence facility in ...
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz.
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...
In 2024, the Food and Drug Administration (FDA) significantly invested in reorganizing its internal infrastructure and enhancing operations. These efforts aimed to address the complexities of a ...
Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. With a large backlog, we’re anticipating a significant ramping up of inspections in different ...
Global contract manufacturing organization (CMO) Symbiosis Pharmaceutical Services has successfully completed the latest inspection by the US Food and Drug Administration (FDA) of its facilities in ...
Emcure Pharmaceuticals announced that the US FDA issued two observations following an inspection at its Pune API manufacturing plant. The US health regulator conducted a cGMP inspection from February ...
Following an inspection of Piramal’s production facility in Maharashtra, India, that ran from Feb. 11 to Feb. 17, the FDA slapped the company with six-observation Form 483 detailing shortfalls ...
This comes following the United States Food and Drug Administration (US FDA) Pre-approval inspection (PAI) for Sterile APIs at the Company’s Facility at JNPC, Visakhapatnam between February 19 ...
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