Among the issues detailed in a Form 483 notice issued by the agency ... the notice was not deemed adequate, so the FDA moved ahead with a warning letter. In a regulatory filing, Applied said ...
Anderson, MS, MBA, is a former FDA Review Chemist with over 43 years ... compliance remediation services to resolve Form 483, Warning Letter, and Consent Decree issues.
In separate DLL3 antibody-drug conjugate (ADC) deals, Roche licensed from Innovent Biologics and Ideaya reached for Hengrui.
In a citizen petition posted by the FDA this week, Novo urged the regulator to restrict the ability of compounding pharmacies ...
A recall of products, including onions, from Gracie's Kitchen has been given a Class II risk classification from the FDA over fears of listeria monocytogenes contamination. The recall impacts ...
Has your company received an FTC warning letter or a penalty offense notice? If so, such correspondence should not be ignored ...
Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.
The FDA has issued an early warning regarding Medline Fluid Delivery Sets, which may pose a significant health risk due to a potentially incorrect assembly, according to a Dec. 30 news release ...
Granules India Confident in USFDA Compliance, Focuses on New Products - Granules India , a Hyderabad-based pharmaceutical ...
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