Maintaining your FDA establishment registration is not just a formality; it’s a vital requirement that safeguards your ability to operate in the U.S. market. From your first submission through the yearly renewal process, accuracy and timeliness are essential. Missing deadlines could mean being removed from the FDA’s active database, creating unnecessary setbacks. Aquila Solutions helps you stay on track, protecting your compliance and keeping your products moving.
Stay Compliant: Keep Your FDA Establishment Registration Active
Who Needs to Register?
Every facility that manufactures, prepares, repackages, or relabels drugs for the U.S. market is required to register with the FDA. This applies to facilities in the United States as well as abroad. Without it, your company will not appear in the FDA’s official listing, putting your ability to distribute products at risk. Active registration is the foundation of both regulatory compliance and uninterrupted operations.
Annual Renewal: A Tight Deadline
Every registration must be renewed each year between October 1 and December 31. Missing this limited renewal period means your registration will lapse, resulting in removal from the FDA’s public database. The consequences can include approval delays, halted shipments, and disruptions across your supply chain. Aquila Solutions ensures your renewal is filed correctly and on time, giving you confidence as you head into the new year.
Why It Matters
Keeping your registration active protects more than compliance—it safeguards your reputation and financial stability. If your registration expires, the FDA may halt product distribution, require additional reviews, and impose delays that stretch for months. This can lead to lost revenue, strained partnerships, and diminished trust from customers and regulators. By staying current, you demonstrate reliability and reinforce your standing in the market.
Why Work with Aquila?
Aquila Solutions manages the entire registration process on your behalf, from preparing initial submissions to handling annual renewals. Our experts know exactly what the FDA requires and ensure every detail is submitted correctly and on time. With Aquila as your partner, you avoid costly mistakes and free your team to focus on advancing your products.
FDA establishment registration is not optional, and the annual renewal period is quickly approaching. Aquila Solutions provides accuracy, timeliness, and peace of mind so you never face gaps in compliance. To learn more about the requirements, you can review the Code of Federal Regulations (CFR) directly or contact our team today to make sure your registration stays active and secure.