Inspections News

Inspections News

Log in or Subscribe Now to 483sOnline.com and get the latest inspection news below and directly to your inbox every week. We track the latest enforcement actions, as well as changes in policy and procedures to keep you in the know!

ARTICLES

Drug

FDA Inspection of Novartis Lab Raises More Questions About Data Falsification

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
Drug

Grassley Calls for Unannounced Inspections of Foreign Drugmakers

Sen. Chuck Grassley (R-Iowa) has urged the FDA to begin inspections of all overseas drug manufacturing facilities without prior notice. Read More
Drug

Spanish Drugmaker Slammed for Serious Violations

A drug manufacturer in Málaga, Spain was cited for failing to test active pharmaceutical ingredients from China and other serious GMP violations. Read More
Device

Radiation Safety Apparel Maker Fails to Report Complaints

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
Device

FDA Warns Clinicon for Lax Testing, Validation of Sterilization Processes

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
Drug

OTC Drugmaker Cited for Equipment, Recordkeeping Issues

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
Drug

Utah OTC Firm Warned for Oversight and Sterility Problems

The FDA hit OTC drugmaker Results RNA with a second warning letter in just over a year, this time for GMP violations at its Orem, Utah facility. Read More
Drug

New Jersey Contract Manufacturer Draws 483 for Quality System Failures

The FDA hit Parsippany, N.J. contract manufacturer Davion with a Form 483 after an inspection revealed failures regarding its quality system and facility management. Read More
Device

California Devicemaker Slammed for Calibration Practices

The inspector discovered that a thermometer used to test the quality of the devices had not been calibrated since at least 2012. Read More
Drug

FDA Warns Biologics Manufacturer for Contamination, Eligibility Concerns

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