March 28, 2018, Lakewood, Colorado – The FDA’s Office of Regulatory Affairs (ORA) performs inspections on all manner of product and program areas including: biologics, drugs, devices, human tissue for transplant, radiological health, foods, and veterinary medicine. When these investigators observe conditions or practices that seem questionable as to whether they comply with FDA requirements, a 483 form may be issued. This list of inspection observations is then provided to the organization to address, and then respond to the FDA notifying them of resolution.
If all observations are taken care of or are at least on a timeline to be handled, most organizations can prevent the issue of a warning letter. A warning letter from the FDA is an official notice that the manufacturer or facility is in violation of FDA rules and regulations.
In 2017, the FDA issued 5,155 warning letters and 420 product recalls. Don’t become part of the statics…