US Food and Drug Administration (FDA) regulators “like to see a focus on Corrective and Preventive Action” (CAPA) after submitting a Form 483 to a study center manager or manager at the end of a condition found inspection issue a sponsor that could be in violation of clinical trial regulations, says Janet Holwell, CCRC, CCRA, TIACR, FACRP, an independent clinical research consultant.
Receiving a 483 can be scary, but Holwell and Glenda Guest, CCRA, RQAP-GCP, TIACR, FACRP, NCRA President, claim the recipient can take advantage of the 15-day period after the form is issued to take advantage of the opportunities Significantly reduce to receiving an even more intimidating Warning Letter from the FDA.
“If the FDA is happy with your response to the 483, then everything is fine,” says Holwell. “If not, a warning letter is not a good thing.” The key to making the FDA “happy” is to have a CAPA program firmly under control and respond in a timely manner with the right amount of detail, adds Holwell.
Use a good CAPA program to “focus on what you’re going to do” to fix whatever problems the FDA lists in the 483, says Holwell. Based on the CAPA plan you provide to the agency, the FDA is looking for you to “show them what you are going to do, your schedule, [and] Your exercise program, ”she notes.
In an upcoming virtual session on the topics of the ACRP 2021 Round in September, Holwell and Guest will walk attendees through the process by highlighting actual FDA-483 responses from sites and sponsors. You will analyze why some responses were effective and why others could not fend off a subsequent warning.
Holwell emphasizes the importance of “crossing the I and dotting the T” in a 483 answer. For example, she cited a warning letter response from a regulated company that was generally solid but did not include the actual CAPA program the company wanted to implement. In this case, the regulated company mistakenly believed that it was enough to simply tell the agency that it had a CAPA program, says Holwell.
Author: Michael Causey