If your life science organization fails to meet regulatory requirements during a Food and Drug Administration (FDA) audit, you can expect to receive a Form 483. While some 483 observations are resolved amicably, other cases have serious consequences for the concerned organization— ranging from warning letters to hefty fines.
Life science industry professionals: You need strategies for not only avoiding 483s, but also for improving all facets of your company’s operations. Clearly, the simplest solution is “to do the right things right!” as regulatory compliance expert Charles H. Paul says. He expands on this solution, detailing seven individual key actions, for establishing any 483 avoidance program in his ProfEdOnDemand webinar, “Avoiding 483’s Throughout Your Organization – Strategies, Risk and Mitigating Approaches.”
Here’s why you need such a program:
The Cost of a 483
You earn a Form 483 after an inspection for conditions that, in the investigator’s judgment, “may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts,” according to the FDA. The 483 notifies company management of objectionable conditions and is presented and discussed with senior management. Companies are then encouraged to respond in writing with their corrective action plan, and implement that corrective action plan expeditiously.
While the cost of a 483 is unique to each organization, the full implications can be staggering. Beyond monetary expenses, a 483 can cost your company: reputation damage, competitor leverage, loss of business, lost stockholder confidence, and diversion from the job at hand.
Unfortunately, most regulated industries don’t have a set approach for developing and integrating compliance program s into the company culture with the specific goal of avoiding 483s—not to mention improving operations, advancing employee competence, and enhancing competitiveness. Compliance and regulatory affairs are viewed in many cases as a requirement to be completed, not an asset that adds value. Time for a mindset change!
Game On: An Insider peek
Chances are high that you will face an FDA inspection, but that doesn’t mean you’re destined to be cited for observations. As you anticipate that dreaded day, don’t stress, keep your cool, and follow these insider tips from Robert Fish who served as an FDA inspector for 33 years:
- Be prepared. Delve into the regulatory compliance programs so you know what to expect from the inspection.
- Train employees. Hold mock inspections so everyone knows what to expect. This could reduce your risk of observations.
- Make a lasting first impression. If faced with an inspection, make sure your workplace is orderly, your equipment clean, and your employees courteous!
- Be honest but brief. When speaking to inspectors, answer questions directly and honestly, but don’t offer extra information.
Achieve Excellence
Practical tips are a great starting point, but being truly prepared for an FDA inspection is deeply rooted in obtaining and properly executing strategies that both avoid 483s and significantly contribute to operational excellence. In order to achieve this, Paul recommends your organization:
- Create a compliance program that helps you avoid 483s.
- Standardize operations and build them around safety and efficacy.
- Structure the organization to exceed your regulatory responsibilities, while at the same time, optimizing every function within the company that the regulatory processes touch.
Your compliance program is a valuable ingredient in the process of running your business. Of course, your organization aims for operational excellence, but harmonizing operations with regulatory compliance—and including technical training—is essential to exceed regulating requirements, Paul notes.