This week FDA posted one letter to a fertility clinic, two to drug manufacturers, and one to a compounding pharmacy, and we cover those here.
Join Lead Quality Systems and Compliance Consultant Steven Niedelman for a comprehensive webinar on what to expect during an inspection as well as the “Do’s and Don’ts” during an inspection.
Join Technical Operations Manager Ernest Blanchard for a comprehensive webinar about the concept of risk management and risk-based thinking within management systems for GxP professionals.
FDA posted three drug GMP warning letters this week to pharmaceutical firms, one to a compounding pharmacy, one to a GLP site, and two to device manufacturers.
In the areas we cover, FDA posted three drug GMP warning letters including one sent to a fertility clinic governed by HCT/P regulations. The other two firms manufacture OTC products. FDA also posted a warning letter to a firm in Ireland, Carahealth, for distributing unapproved and misbranded products related to coronavirus disease.