“The best way to survive an FDA inspection is to always be prepared for one,” advises Michelle Anantha, MSPAS, PA-C, RAC (US), with the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), Office of Compliance, Office of Scientific Investigations, Division of Enforcement and Postmarketing Safety, Compliance Enforcement Branch.
If that sounds easier said than done, Anantha does offer some insights on how to handle receipt of an FDA Form 483, the field investigator’s observations of possible deviations from federal regulations, but not necessarily regulatory violations. The 483 is issued to the highest management official at the end of the inspection. FDA expects a written response within 15 days after the close of the inspection to the field investigator’s office.
Take the deadline seriously, Anantha suggests. Turning your response in late “may be considered [negatively] in an FDA compliance decision,” she notes. On the other hand, turning in a well-crafted response within the timeframe “demonstrates your commitment to correct the observations to the FDA, i.e. [your] intent to voluntarily comply,” she adds. Finally, it’s just common sense to understand that respecting the agency’s request helps to establish “credibility” with regulators, she says.
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Responding to a 483 takes work, Anantha acknowledges. “You should ensure that the communication provides an adequate response to FDA’s observations, is easy to follow, and there are corrective actions in place to fix the issues” raised by the inspector, she says. “Each response should address the central issues raised in the observations and provide factual objective evidence that permits evaluation and aids in understanding of the response.”
She also shares some of the common characteristics of effective 483 responses:
- Include a commitment from senior leadership
- Address each observation separately
- Note whether you agree or disagree with the observations
- Provide both corrective and preventative actions
- Provide both completed and planned actions
- Provide timelines for completion of the actions
- Provide a method of verification or monitoring of the effectiveness of the actions
- Submit documentation such as training, standard operating procedures, and other records
Anantha presented her remarks to the CDER Small Business and Industry Assistance FDA Clinical Investigator Training Course on November 13 in College Park, Md.
Author: Michael Causey