CAPA Prowess Key to Defusing Thorny FDA Inspections

Janet Holwell, ACRP, Fellows, Testimonial

Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer

Regulators for the U.S. Food and Drug Administration (FDA) “like to see a focus on corrective and preventive actions” (CAPAs) after they issue a Form 483 to managers of a study site or sponsor at the conclusion of an inspection that found any conditions that may constitute violations of the regulations for clinical trials, says Janet Holwell, CCRC, CCRA, TIACR, FACRP, an independent clinical research consultant.

Receiving a 483 can be scary stuff, but Holwell and Glenda Guest, CCRA, RQAP-GCP, TIACR, FACRP, president of NCRA, maintain the recipient can use the 15-day period after issuance of the form to greatly reduce the chances of receiving an even more intimidating Warning Letter from the FDA.

“If the FDA is happy with your response to the 483, all is good,” Holwell says. “If not, a Warning Letter is not a great thing to get.” Key to making the FDA “happy” is demonstrating a firm grip on a CAPA program and responding with the right amount of detail in a timely fashion, Holwell adds.

Leverage a good CAPA program to “focus on what you will do” to remedy whatever issues the FDA cites in the 483, Holwell says. Based on the CAPA plan you provide to the agency, the FDA is looking for you to “show them what you will do, your timetable, [and] your training program,” she notes.

In an upcoming virtual session for ACRP 2021’s round of September topics, Holwell and Guest will guide attendees through the process by highlighting actual FDA 483 responses from sites and sponsors. They’ll dissect why some responses were effective and why others weren’t able to fend off an ensuing Warning Letter.

Holwell stresses it’s important to “cross the I’s and dot the T’s” in a 483 response. For example, she cites a Warning Letter response from a regulated entity that was generally solid, but that failed to include the actual CAPA program the entity intended to implement. In that instance, the regulated entity wrongly believed that it was enough to simply tell the agency it had a CAPA program teed up, Holwell says.

Author: Michael Causey