FDA Warning Letter Recap

The US Food and Drug Administration released five warning letters last month, showing an ongoing focus on premarket clearance and the quality system regulations compliance.

The US Food and Drug Administration released eight warning letters and one close-out last month. Big names caught in the net included Beckman Coulter, Royal Philips and Cardinal Health.

This week, Philips Respironics reached a $1.1b settlement affecting CPAP and other breathing devices. Toku announced it received US FDA breakthrough device designation for its MyKidneyAI technology. This May, the FDA will hold its REdI conference focusing on innovation in medical product development and hold another townhall focusing on considerations for selecting a sterilization modality.

The number of class I medical device recalls has increased over the last decade, and that concerns officials at the FDA.

The US Food and Drug Administration released seven warning letters in March 2024, of which three were related to a recent crackdown on China-made syringes. Other letters recounted troubles at Exactech, Fresenius and ReNovo, as well as clinical trial violations from Nobles Medical Technology.

This week, the US FDA issued an update on its safety warning for plastic syringes made in China; AdvaMed announced a medical device and diagnostics statistical conference in collaboration with the agency; the FDA is looking for comments on its TAP Pilot and published two warning letters for high-profile recalls. 

The US Food and Drug Administration has released three warning letters and two close-outs so far this year, with missives citing problems with premarket authorizations, quality systems compliance and reporting.

The US FDA issued a stern warning to Fresenius Medical Care over its slow approach to corrective actions over potentially harmful toxins emitted from its hemodialysis machines and accessories.

The US Food and Drug Administration released three warning letters in December 2023, with missives going to device makers in Germany, Sweden and Argentina. No close-out letters were issued last month.

The US Food and Drug Administration issued three device-related warning letters in November, which went to manufacturers in Texas, California and China. Additionally, a 2018 warning letter to South Korean firm Dexocowin has been resolved.

The US Food and Drug Administration issued two device-related warning letters in October, one to Abiomed and one to WAVi Co.

A warning letter from the US FDA to device manufacturer Abiomed highlights industry’s criticism that the agency’s final guidance on clinical decision support software is flawed and oversteps regulatory boundaries.

It was a quiet month for warning letters at the FDA last month, with the agency issuing no new warning letters and closing out only one. 

The FDA issued warning letters to three US device firms last month, as well as closing out a 2021 letter to Invacare.

After an inspection of its Boston facility, the US FDA issued a warning letter to Integra LifeSciences' subsidiary TEI Biosciences for distributing collagen-based medical devices that failed bacterial endotoxin tests and did not conform to good manufacturing practices.

Following a recent warning letter from the US Food and Drug Administration, Outset Medical has stopped distribution of the TabloCart, an accessory to its Tablo Hemodialysis System.