The possibility of receiving an FDA (the United States Food and Drug Administration) warning letter is one of the most severe obstacles faced by firms operating in the biologics industry. An, FDA warning letter is a formal notification of one or more serious violations.
The FDA defines a warning letter as:
“A letter notifying a regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations, and other federal statutes.”
If your company receives such a notice of noncompliance from the FDA, you should immediately contact an experienced FDA defense attorney. Not responding or responding incorrectly could result in formal civil and criminal investigations against your company.