FDA Due Dilligenc​e Review

FDA Due Diligence Review

Congratulations, you sold or are planning to sell your company. Whether that’s a medical device, drug, food, dietary supplement or cosmetic company, you need to prepare for an FDA due diligence review. An FDA due diligence review is an opportunity for the buyer to review your company’s regulatory compliance, compliance history, and regulatory risk exposure, i.e., how likely is FDA enforcement action.

FDA due diligence involves three primary areas. They are:

• Pre-market compliance;
• Labeling; and
• Post-market compliance.

Pre-market compliance can include a range of activities. For a food or dietary supplements, this often focuses on ingredient compliance, in particular, whether an ingredient is GRAS (generally recognized as safe) or is a New Dietary Ingredient. It could also focus on Food Facility Registrations, Food Canning Establishment registrations, and/or SIDs (process filings). For cosmetics, often the main focus is on color additives. Medical devices and drugs can be the most involved, including an assessment of classification, any pre-market application exemptions claimed, the status of any pre-market applications, and any modifications. It would also include any registrations, including three-part drug registration and registration of any contract manufacturers.

Labeling in any product category is more than the physical packaging but can extend to websites, social media, testimonials, paid reviews, and videos. Even Amazon reviews still pose a risk and merit review. A label review for each product category is looking for different issues but is key to any FDA due diligence review.

Post-market compliance focuses on GMPs or Good Manufacturing Practices. GMPs aren’t just for manufacturers but any private labeling who should be auditing suppliers, tracking complaints, and maintaining procedures for recalls and reporting.

An FDA due diligence review is a multi-factor analysis that is specific to each company. Given the potential depth and complexity, it’s important to plan ahead.

FDA Due Diligence Review