Got a Form 483? Then you’ve got 15 days. Starting today, FDA will enforce its program that calls for a more timely review of its Form 483 Inspectional Observations. Under this program, a company has 15 days to respond to the observations cited in the agency’s Form 483, before the agency decides whether to issue an official warning letter. The goal of this program is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations.
Before this program, according to the agency, some firms submitted multiple and delayed written responses to Form 483 observations, sometimes over many months. Because FDA reviewed all of these responses before making a decision on whether to issue a warning letter, the process delayed enforcement and compliance. Now, however, FDA “will not ordinarily delay the issuance of a warning letter in order to review a response to an FDA 483 that is received more than 15 business days after the FDA 483 was issued,” according to an announcement in the Federal Register.
If a response to a Form 483 is received after 15 business days, FDA says it does not plan to “routinely include a response on the apparent adequacy of the firm’s corrective actions in the warning letter.” Instead the agency “plans to evaluate the response along with any other written material provided as a the direct reponse tot he warning letter.” FDA maintains the discretion to issue a warning letter regardless of whether any responses are received.
The program appears to apply the 15-day limit regardless of the number of observations on the Form 483. One hopes this program will help add a greater level of urgency, especially in situations that apparently have not been taken seriously until a warning letter has been issued. I do not want to think some firms may have deliberately delayed compliance by submitting their responses weeks apart, but I can see how the assumption can be made. On the other hand, investigating the cause of some observations and developing a corrective action can be a time-consuming process such that delayed and multiple responses are not uncommon. One hopes, then, this program will be a good first step toward achieving the tough, no-nonsense enforcement the agency needs without also overburdening the industry.