510(k) Submission Repair

RQMIS Resolves 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 based on evidence provided by state personnel.

The situation: The FDA issued a warning letter to a medical device manufacturer of a critical long term implant after an inspection. A warning letter is a public document that is accessible by not just the target company and FDA, but also by competitors and prospective clientele. In this instance, a competitor used this document to edge out the manufacturer during contract negotiations, resulting in a loss of prospective business.

RQMIS was tasked with helping the manufacturer address the issues targeted in the FDA warning letter in a timely and effective manner. RQMIS needed to keep the business operational and stop the loss of potential customers.

In the six months following the manufacturer’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 sale of 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.

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