The U.S. Food and Drug Administration has warned the pharmaceutical company Sanofi about significant deviations from Current Good Manufacturing Practice for active pharmaceutical ingredients at their ...
Strategic collaboration at Sanford, North Carolina facility, currently under construction, to optimize cGMP validation, accelerate time-to-market ...
The US Food and Drug Administration (FDA) has hit Philips with a warning letter after quality control shortcomings were uncovered at three of its medical device manufacturing sites. Issued on 9 ...
The US Food and Drug Administration (FDA) has released a draft guidance detailing how manufacturers should address Form 483 observations following a drug good manufacturing practice (GMP) inspection.
On June 18, 2026, the Food and Drug Administration (“FDA”) announced the submission of a proposed collection of information ...
Manufacturing-related cGMP observations at a former contractor, not cytisinicline-specific quality failures, and incomplete labeling formed the basis of the CRL rather than clinical concerns. Achieve ...
The US Food and Drug Administration (FDA) is releasing a final guidance on positron emission tomography (PET) products to help manufacturers of the drugs meet the agency's requirements for good ...
Our FDA: Compliance & Enforcement Team explores the U.S. Food and Drug Administration’s new draft guidance on responding to FDA Form 483 observations at the conclusion of an inspection. The FDA’s ...
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