Regulatory Strategy for FDA Warning Letter

What is an FDA Warning Letter?

An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA can determine violations based on its own inspections or evidence provided by state personnel.

THE SITUATION

Following an FDA inspection, a medical device manufacturer of a critical long-term implant received a dreaded FDA warning letter. Warning letters are public documents that are accessible by not just the target company and FDA, but also by competitors and prospective clientele. In this particular case, a competitor, unfortunately, used this document to edge out the manufacturer during contract negotiations which resulted in the loss of prospective business. Needless to say, the manufacturer was eager to find a quick resolution to satisfy the FDA.

THE SOLUTION

RQMIS was tasked with helping the manufacturer address the issues targeted in the FDA warning letter in a timely and effective manner. We needed to keep the client's business operations and stop the loss of potential customers. In the six months following the client's receipt of the warning letter, RQMIS:

• Designed a corrective action (CA) plan within the first two weeks
• Provided ongoing strategy
• Updated the manufacturer’s Quality Management System
• Communicated the action plan and negotiated a mutual agreement between the manufacturer and the FDA to continue the sale of the product
• Generated a robust plan that included a dozen corrective and preventative actions (CAPAs) managed jointly by RQMIS and the manufacturer’s internal staff that included:
  • Regular effectiveness checks
  • Ongoing status checks
  • Internal auditing
  • CAPA closure and warning letter removal
• Assured that the client continued to comply with EN/ISO standards

Our team's quick and effective action let the manufacturer continue selling medical device products just two weeks after the issuance of the FDA warning letter, which reduced the impact of the letter on the function of the business. The FDA completely removed the warning letter after only six months, coinciding with the completion of the CAPA plan.