An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated certain rules in a federally regulated company. The FDA can identify violations based on inspections or on their own evidence from government personnel.
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After an FDA inspection, a critical long-term medical implant manufacturer received an eerie warning letter from the FDA. Warning letters are public documents that can be accessed not only by the target company and the FDA, but also by competitors and potential customers.
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The FDA issues a warning letter when a company has committed a serious offense. This is the Agency's primary way of communicating with offenders and the first step in enforcing the rules.
In the case of manufacturers of health products, this may include, but is not limited to, illegal or fraudulent marketing practices, or non-compliance with current good manufacturing practices (CGMP) that ensure product safety.
The warning letter also includes instructions on what action to take to remedy the situation, as well as a number of deadlines to notify the FDA of the company's progress. During this time, the FDA will periodically monitor these violations to take certain corrective action. If the company does not comply, additional steps can be taken.
The FDA can identify violations as part of its own inspection. Additionally, the authorities can find out about violations at the state level. In either case, a warning letter is only the first step, allowing the company to voluntarily send out advance notice before taking further action.