How to Handle an FDA 483: Your Ultimate Survival Guide

Imagine this: You’re in the middle of a busy workday, juggling emails and…


FDA Recall Management: What You Need To Know

Imagine this: It's a bright Monday morning, and a well-known food brand is…


FDA inspector reviewing compliance documents during an FDA audit

When FDA Shows Up Unannounced: Top Tips for Surviving an FDA Inspection

Picture this: you’re sipping your morning coffee, catching up on emails, and…


You Received an FDA Warning Letter, Now What?

Receiving an FDA warning letter can be a daunting experience for any business…


FDA Claims: Considerations Based on What NOT to Do

A question often asked by clients in FDA regulated industries is, “what claims…


What are FDA Export Certificates?

What are FDA Export Certificates? Businesses looking to export food, dietary…


FDA Publicizes OMUFA Fees Arrears List 2021

FDA Publicizes OMUFA Fees Arrears List 2021 Facilities who have not complied…


Reminder: FDA is Now Beginning To Collect OTC Monograph User Fees

Reminder: FDA is Now Beginning To Collect OTC Monograph User Fees As we…


FDA Releases First-Ever OTC Monograph Facility Fees For 2021, exempting some hand sanitizer makers

FDA Releases First-Ever OTC Monograph Facility Fees For 2021, exempting some…


Hand Sanitizers From Mexico On Import Alert- FDA

Hand Sanitizers From Mexico On Import Alert- FDA “FDA has taken action to…