"At the end of the inspection, a 'Form 483' has been issued with 9 observations. With respect to the mentioned inspection, we have received a letter from USFDA classifying the inspection as ...
The U.S. Food and Drug Administration has lifted a clinical hold on three cell therapies being developed by CARsgen ...
the agency issued a Form 483, with five observations, the filing said. "We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these ...
Mumbai: Cipla has announced that the United States Food and Drugs Administration (USFDA) has concluded an inspection at the ...
"At the end of the inspection, the agency issued a Form FDA 483 with one observation which is procedural in nature," it added ...
As per the form 483 issued by inspector Cynthia Jim, consumer safety officer, the US FDA found the company’s Nagpur facility deficient on five counts. The first observation on the unit was ...
The FDA also cited inadequate control over computers and other IT systems, as well as poor communication and compliance with ...
Drug maker Cipla on Wednesday said the US health regulator has issued eight observations after inspecting its Bengaluru-based ...
FDA’s Form 483 cited critical lapses ... Humacyte’s approval timeline could face further delays due to compliance issues. Regulatory and legal pressures may impact the company’s stock ...
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