pharmaphorum13d
As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever
so sites must reevaluate their quality and safety credentials and maintain a state of good manufacturing practice (GMP) readiness. Throughout the pandemic, the lack of FDA inspections has created ...
Cryoport facilities land FDA approval
It's one of many steps for the company as it builds the infrastructure for what "will change medicine everywhere in the world ...
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA ...
Fox News1mon
Costco-brand cold and flu medication recalled by FDA: 'Not effective'
The FDA stated that the Kirkland recall was ... most likely occurred due to deviations from CGMP (Current Good Manufacturing Practice). "[That means] the product failed to meet required quality ...
JD Supra5d
FDA Draft Guidance Addresses Management of Environmental Pathogen Hazards for Low-Moisture Ready-to-Eat Foods
On January 6, the U.S. Food and Drug Administration (FDA) issued long-awaited draft guidance regarding Establishing Sanitation Programs ...
Daily1d
Gland Pharma gets USFDA EIR for Pashamylaram facility
Telangana: Gland Pharma has received Establishment Inspection Report (EIR) from the United States Food and Drug ...
Gland Pharma facility in Hyderabad gets EIR from U.S. FDA
Gland Pharma receives EIR from US FDA for Dundigal facility, indicating closure of inspection with no major concerns.
The American Journal of Managed Care1mon
FDA Rejects Subcutaneous Amivantamab for NSCLC Over Manufacturing Concerns
The FDA rejected J&J's subcutaneous amivantamab due to manufacturing issues, not safety or efficacy concerns, affecting only the new formulation. The subcutaneous version aimed to provide a more ...
The Victoria Advocate13d
Cryoport's MVE Biological Solutions Registers All Manufacturing Facilities with the U.S. Food and Drug Administration ("FDA")
including but not limited to 21 CFR Part 820 and Good Manufacturing Practices ("GMP"). This FDA registration and product listing is in addition to MVE's existing ISO 13485 certification.