Warning Letters

Regenerative Processing replaces nozzle to prevent backflow for its Regener-Eyes drops but FDA warning states numerous questions about sterility at the firm’s plant and about its procedures and systems for preventing microbial contamination.

The US Food and Drug Administration released three warning letters last month, two of which went to Chinese device testing labs accused of improper treatment of laboratory animals.

Green Pharmaceuticals’ SnoreStop Nasal Spray, previously marketed as “NasoSpray,” still is available even though agency officials on multiple occasions for a month recommended a recall after an April inspection found “gross microbial contamination” in one lot.

Zydus Lifesciences must provide the US Food and Drug Administration with a detailed action plan addressing specific violations of current good manufacturing practice at its injectables site in Vadodara, Gujarat.

The US Food and Drug Administration released six warning letters and two close-outs last month, including four warnings to marketers of unauthorized continuous positive airway pressure (CPAP) cleaners or sanitizers.

This week, surgical robot maker Globus Medical got a warning letter from the US Food and Drug Administration; the FDA cleared a hemostatic gel to stop blood loss; Medicare issued a payment code for Medtronic’s renal denervation device; and more.

Request to recall eye drops should be fulfilled promptly and businesses providing lip balms as promotional products must verify contract manufacturers are compliant, recent FDA warnings states. Additional letters went to Jordanian firm about testing alcohol for methane and to a Chinese firm advised that compliance with China’s quality control standards isn’t sufficient.

Consumer health, particularly food supplements that make unauthorized medical or health claims, has been a key area of focus for the UK Advertising Standards Authority's recently introduced Active Ad Monitoring system, which captures ads by relevant advertisers from a range of social media platforms, and applies machine learning algorithms to identify and flag likely non-compliant ads, which are then sent to experts to review and act on. This infographic highlights recent ASA rulings against ads for supplements claiming to treat anxiety and stress, menopause, autism/ADHD and weight loss, which were flagged by AI.

This week, the US FDA sent a warning letter to maker of batteries for AEDs, AMCO; Virtual Incision successfully completed the first hysterectomy its miniaturized robotic-assisted surgery device MIRA; The DOJ finalized a rule that requires government-operated health care facilities to provide accessible equipment for people with disabilities; the FDA compiled its resources on reprocessed medical devices onto a new web page; and more.

The US Food and Drug Administration released five warning letters and two close-outs last month, including two warning letters to Chinese makers of plastic syringes.