Be ’Recall Ready’: FDA Wants to Help You Fulfill Your Regulatory Requirements

By Eric Foxman, AAHP Secretary

Does your company market or distribute an FDA-regulated product? If so, then FDA has a document for you.

FDA wants all manufacturers and downstream distribution faculties to be prepared with a recall plan so they can quickly and effectively react if a violative product needs correction or removal from the market. The recall plan should be in place before it might be needed. To help companies, the agency has finalized and posted a product recall guidance document that offers processes to implement a plan. The document includes a section on the essential communications during a recall operation. This is in addition to the highlights on preparing, maintaining, and documenting recall procedures, as well as training identified personnel.

FDA’s goal is to minimize consumer exposure to potentially harmful products as quickly as possible. We may instinctively think it doesn’t apply to our industry because homeopathic products are inherently safe. However, there have been homeopathic product recalls in the last years – mostly due to unresolved cGMP compliance issues.

The guidance document also offers recommendations on how to put a recall plan in place. It is a tool worth using, as it could initiate your company’s planning or serve as an outside checklist of your existing plans.

There are numerous companies that can help our industry members properly develop appropriate and effective recall plans. EAS, the company which recently presented an AAHP Compliance Through Education webinar on cGMPs, can be one such source of support.