Inspections News

Device

National Biological Lands Warning for Improper Nonconformance Procedures, Complaint Handling

The FDA warned National Biological Corp. for failure to thoroughly investigate complaints and improper handling of out-of-spec products. Read More
Device

Whitehall Manufacturing Draws FDA Warning for Therapy Devices

Whitehall Manufacturing received a warning letter for multiple violations concerning its whirlpool immersion hydrotherapy and dry heat therapy devices. Read More
Drug

Facility Inspections Factor in Slow Generics Reviews, Says GAO

The FDA is improving its response times for generic drug applications, but facility inspections remain a major hang-up in the process, according to a GAO report. Read More
Drug

Strides Gets 483 for Quality Problems

Bangalore-based pharmaceutical company Strides Sashun, formerly known as Strides Arcolab, was recently cited by the FDA for quality problems with pills bound for U.S. markets. Read More
Device

What Device Manufacturers Can Learn From FDA’s Inspection Data

Medical device quality managers that don’t want to wind up a statistic in a future FDA report on quality deviations should dig deeply into the agency’s recently released report on inspections, Form 483s and warning letters, says Michael Gaba, a partner in the law firm Polsinelli. Read More
Device

CarboFix Receives 483 for Various Quality Infractions

The FDA hit CarboFix Orthopedics on MDR submissions, anti-contamination efforts and quality audits. Read More
Drug

Vista Pharmaceuticals Warned on Facility Disrepair, Other Violations

FDA investigators visiting a Vista Pharmaceuticals plant in Nalgonda, India found equipment used to manufacture drugs riddled with holes and corrosion, according to a warning letter issued July 5. Read More
Drug

Texas Pharmacy Warned on Sterility and More GMP Violations

A complaint about ineffective erectile dysfunction drugs led to an FDA inspection of a Texas-based compounder, resulting in a lengthy warning letter from the agency detailing sterility concerns. Read More
Device

MHRA Updates Guidance on UK Notified Bodies

In a decision associated with the United Kingdom’s withdrawal from the European Union, the UK’s Medicines & Healthcare products Regulatory Agency issued updated guidance with new links to notified bodies permitted to undertake conformity assessments of medical devices in the UK. Read More
Device

FDA Hands OsteoSymbionics a 483 for CAPA, Nonconformance Issues

Devicemaker OsteoSymbionics must correct several problems uncovered by FDA investigators, including CAPA procedures and non-conforming materials reports (NCMRs). Read More