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A Form 483 issued following an FDA inspection of Novartis subsidiary AveXis’ control testing laboratory — currently the focus of a data manipulation investigation by the agency — is raising concerns about the firm’s own investigation and when it knew about the data discrepancies. Read More
Devicemaker Protech Leaded Eyewear failed to develop Medical Device Reporting procedures and didn’t investigate complaints, the FDA’s Dec. 6-14, 2018 inspection of its Lake Park, Florida plant revealed. Read More
The FDA issued a June 20 warning letter to Clinicon for quality system lapses related to its SureProbe Class II sterile probe following an April 3-4 inspection of the firm’s Oceanside, California facility. Read More
Over-the-counter drug manufacturer Church and Dwight was hit with a Form 483 for violations at its Lakewood, New Jersey facility, including incomplete laboratory records and shortcomings in its microbiological testing. Read More
The FDA slapped human cells, tissues, and cellular and tissue-based products (HCT/P) manufacturer Stratus BioSystems with a warning letter for violations at its Grapevine, Texas facilities involving its Amniotic Membrane Patch Allograft product. Read More