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Aurobindo Pharma's U.S. plant receives 11 observations from FDA, no impact on operations, response to be submitted.
Aurobindo Pharma Ltd on Friday said the US health regulator has issued a Form 483 with 11 observations to the Raleigh plant ...
The inspection was completed on 10 April 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature. Disclaimer: No Business Standard ...
Aurobindo Pharma received a Form 483 with 11 observations from the USFDA for its Raleigh plant in North Carolina. The company ...
At the conclusion of the inspection, the US FDA issued a Form 483, listing 11 observations. Aurobindo Pharma characterised ...
US FDA inspects Science 37’s Direct-to-Patient Site for clinical research in phase 3 asthma trial; no objectionable conditions noted: Morrisville, N.C. Thursday, April 10, 2025, ...
Shilpa Pharma Lifesciences has successfully passed a U.S. FDA inspection for its Unit-2 facility in Raichur, India, with no 483 observations.
Science 37, a leader in enhancing patient access to clinical trials, today announced the successful completion of its second FDA inspection, reaffirming the quality of its Direct-to-Patient Site for ...
In every corner of the FDA, and at sister health agencies like the CDC, support staff, specialists, and scientists were hit with DOGE pink slips.
WuXi AppTec, a global company that provides a broad portfolio of R&D and manufacturing services to enable companies in the ...
This is the fourth time that Langhua Pharmaceutical has undergone and passed the on-site inspection by the FDA, indicating the effective operation of the Company's quality control system.
So far, the FDA says there is no word of anyone becoming ill from the Coke products. On Monday, the FDA labeled the advisory as a Class II recall, which means the risk of getting sick is remote.