FDA 483 - Senores Pharmaceuticals - March 28, 2025

This FDA Form 483, issued on March 28, 2025, to an unnamed firm, outlines significant observations made during an inspection. The primary issues identified relate to the company's failure to adhere to regulatory timelines for submitting adverse drug experience reports, which are crucial for drug safety monitoring.Specifically, the inspection revealed that the firm did not submit 21 of its quarterly periodic adverse drug experience reports within the required 30-day timeframe for eight out of 16 approved drugs. Examples include delays for Butalbital, Acetaminophen and Caffeine Capsules, Mexiletine Hydrochloride capsules, and Ketorolac Tromethamine Tablets, with submission dates ranging from one day to several months past their due dates.Furthermore, the document noted that three annual periodic adverse drug experience reports were not submitted within 60 days of the anniversary date of drug application approval, affecting three out of 16 approved drugs. These delayed submissions included reports for Ketoconazole Tablets, Amphetamine Sulfate Tablets, and Hydroxychloroquine Sulfate Tablets, with some delays extending to several months.These observations indicate a lapse in the firm's compliance with established pharmacovigilance regulations, which mandate timely reporting of drug safety information. While the Form 483 itself does not prescribe specific actions, these findings typically necessitate the company to promptly investigate the root causes of these reporting failures and implement robust corrective and preventive actions to ensure all future adverse drug experience reports are submitted accurately and on schedule, thereby upholding public health safety standards.