Inspections and Audits


EpiPen Manufacturer Bungled Response to Complaints of Failures, FDA Says

A company that manufactures EpiPens neglected to follow up on hundreds of complaints that the epinephrine injectors failed to operate during life-threatening emergencies, including some that resulted in patients’ deaths — and the company did not recall potentially defective injectors from the marketplace even after identifying a fault in a critical injector component, the FDA said in a warning letter. Read More

German Sunlamp Company Burned in FDA Warning Letter

A German sunlamp manufacturer failed to measure up to several quality standards in an inspection of its plant in Berlin, and the FDA moved to bar imports from the company to the United States, the agency said in a warning letter. Read More


Making Sense of IVD Regulation - Webinar Recording/Transcript

Devicemakers, IVD marketers and clinical labs struggle often with FDA regulation — and it’s no wonder. The rules governing IVDs are scattered throughout the CFRs , and exceptions, special cases and pitfalls abound. Some hapless firms have even followed the wrong set of rules — and endured 483s or warning letters as a result. View

CDRH in Transition: Navigating the New Culture of Quality

In CDRH in Transition: Navigating the New Culture of Quality he explains why compliance and quality don’t necessarily go hand-in-hand and how the center’s GMP inspections program intends to increasingly emphasize what a company is doing right over dinging them for what they’ve done wrong. View

Process Capability Indices for Medical Device Manufacturers - Webinar Recording/Transcript

In device manufacture, QSR requires, where appropriate, procedures for valid statistical techniques to establish, control and verify process capability acceptability. Particularly tricky: calculating process capability indices using data from Statistical Process Control (SPC), predominantly x-bar and R charts. Master that and you’re well on your way to cleaner inspections. View

Global Regulation Under Gottlieb-Trump and a Look Ahead - Webinar Recording/Transcript

In Part IV of FDAnews’s Expert Insight Series, our panelists look overseas to evaluate drug and device regulation globally, and venture educated guesses concerning the direction of drug and device regulation in 2018 and beyond. View

Pharmaceutical Regulation Under Gottlieb-Trump - Webinar Recording/Transcript

In Part III of FDAnews’s Expert Insight Series, our panel takes up drug regulation, policy and enforcement. View

Device Regulation Under Gottlieb & Trump - Webinar Recording/Transcript

In Part II of FDAnews’s Expert Insight Series, our panel dives deep into device regulation, policy and enforcement. View

What We’ve Learned Since Scott Gottlieb Was Confirmed - Webinar Recording/Transcript

FDAnews has assembled a standout panel — five top experts, four of them ex-FDAers — to bring their insights to bear on how the Gottlieb FDA will impact your products and programs. View

China’s Medical Device Regulations - Webinar CD/Transcript

China, the hottest medical device market on the planet, is welcoming U.S. devicemakers. A push is on to streamline importation of medical devices, including letting U.S. drugmakers set up production in China and collaborate with local manufacturers. The price is a familiar one: Compliance with China’s regulations. View

Transforming the Medical Device Critical Process Supply Chain - Webinar CD/Transcript

Now, FDAnews has brought together two MedAccred thought leaders (from J&J and Stryker), plus a MedAccred suppler (Global Technologies) for presentation introducing you to this innovation in supply-chain auditing. View

Cybersecurity and Risk Management for Medical Devices - Webinar CD/Transcript

If your medical devices incorporate software, they may be targets for cyber-crooks. It’s time you adopted a strategy to gain information, evaluate it, and take action — including regulatory responsibilities. This FDAnews presentation provides the regulatory information you need to stay compliant. View

Combination Products: Managing Design Controls - Webinar CD/Transcript

Planning to submit a new combination product for FDA approval? The final guidance regarding Current Good Manufacturing Practice Requirements for Combination Products — the document that may hold the key to success or failure — is a lot more nuanced than many realize. View

Using CDRH’s Medical Device Quality Data to Improve Your Bottom Line - Webinar CD/Transcript

The “CY2016 Annual FDA Medical Device Quality System Data” report is an information goldmine for devicemakers — a key to better inspection outcomes as well as greater quality in manufacturing. View