FDA Warning Letters


FDA Warning Letters are notifications issued to manufacturers found to be in significant violation of federal regulations. Warning Letters represent serious regulatory violations, and require prompt corrective action from the recipient.

Through audits or inspections, FDA may find that a medical device manufacturer is in violation of the federal Food, Drug, and Cosmetic Act (FDCA). Violations may include inadequate maintenance of complaint files, inappropriate claims about what the product does, flawed design controls, and other problems. FDA issues Warning Letters to companies when there is indication that a serious violation has occurred.

FDA Warning Letters include a detailed explanation of the specific violation and require an immediate response from the manufacturer explaining the corrective action that will be taken. It is important to note that Warning Letters are issued only for violations of regulatory significance, meaning they may lead to enforcement actions if corrective actions are not taken.

FREE RESOURCE: Click here to download our checklist for responding to FDA 483s and Warning Letters.

What do FDA Warning Letters Mean to Medical Device Companies?

In Fiscal Year 2018, the most common quality system violations noted in FDA Warning Letters were related to procedures under the medical device quality system regulation 21 CFR Part 820 for Design Controls (820.30), Complaint Files (820.198), and Corrective and Preventive Action (820.100). 

For a medical device company, FDA Warning Letters can delay or prevent premarket approval of medical devices. In addition, Warning Letters are published on the FDA website to protect patients and encourage manufacturers to take prompt action. Further, there are several potential legal ramifications. The FDA Warning Letter:

  • Serves as prior notice should the FDA decide to take regulatory action;
  • May be introduced as evidence in a product liability lawsuit;
  • May serve as evidence of a company’s knowledge of a defect in a civil lawsuit;
  • May be used by a plaintiff to persuade the jury that the FDA endorses the plaintiff’s claim.

Enforcement actions may be taken if the violations are not addressed in a timely and thorough manner.

Connection between FDA Warning Letters and 483 Observations

Unlike an FDA Warning Letter, Form 483 does not represent an FDA determination of violations. Instead it is meant to be a guide for corrective actions to be taken by the manufacturer based on an FDA inspectional review.

FDA inspects manufacturers of Class II and III medical devices at least every two years. In addition, inspections may occur under a variety of circumstances:

  • In response to third-party complaints,
  • Evaluation of a new facility or a facility under new management,
  • Follow up to assess corrective actions, and
  • Pre-approval inspections.

A written response to Form 483 Inspectional Observations is required within 15 working days. Not all Form 483 Observations result in a Warning Letter, but a company’s response may be used to gauge its willingness to comply with FDA regulations or to determine the need for follow up action. If a company’s response to issues documented with Form 483 is considered to be inadequate, or the violations are of a particularly serious nature, then an FDA Warning letter may be issued.

How Should I Respond to FDA Warning Letters?

FDA Warning letters represent violations that may lead to regulatory action if not addressed properly. Like Form 483 observations, Warning Letters require a response within 15 working days. The response should include:

  • Immediate acknowledgement of receipt of letter,
  • Creation of a Corrective and Preventive Action plan,
  • Provision of a timeline to the FDA if corrective actions will take more than 15 business days, and
  • Implementation of the plan prior to follow-up inspection.

A primary goal of the company should be to reassure FDA that the product or practice in question is safe and effective, so all responses should be crafted with this in mind. It should be straightforward and clearly demonstrate how the issues raised in the FDA Warning Letter will be corrected. Unsupported claims should be avoided in the response to an FDA Warning Letter.

The quality and thoroughness of the response will often determine whether or not escalation to further regulatory or legal action is necessary.

How Greenlight Guru Helps Companies Avoid FDA Warning Letters

Understanding FDA Warning Letters and how to appropriately respond to them is critical for any medical device company. But taking proactive steps to prevent the violation from occurring is a more effective, safe, and cost-saving approach. By focusing on quality, and not solely compliance, medical device companies decrease the likelihood of receiving complaints and investigations that escalate to Form 483 observations and FDA Warning Letters.

Greenlight Guru's medical device QMS software is an excellent starting point for medical device manufacturers who want to be sure they produce the safest and highest quality medical devices. Regulatory standards and best practices are built into the purpose-built software, so your team can focus on innovating products and improving the lives of patients.

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