It Starts and Stops at the Top: FDA Issues Warning Letters for Lack of Corporate Oversight

The Food and Drug Administration issued two Warning Letters recently to pharmaceutical manufacturers where lack of corporate oversight was an issue. These Warning Letters reaffirm that senior management cannot delegate or contract away its regulatory responsibilities.

Highlights

  • In one case, FDA previously cited the company for current Good Manufacturing Practices deficiencies.
  • The agency noted repeat quality-related observations at multiple sites.
  • FDA wrote:

    These repeated failures at multiple sites demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

    Your executive management remains responsible for fully resolving all deficiencies, and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements.

  • FDA specifically asked the company to provide, in its response to the Warning Letter, “A management strategy for your firm that includes the details of your global corrective action and preventative action plan. (Emphasis added.)
  • In the second Warning Letter, FDA cited the company for quality-related deficiencies. It reminded the company:

    Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors, such as product facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

    You are responsible for the quality of drugs you produce as a contract facility, regardless of agreements in place with product owners.

AGG Observations

  • We have written about contract manufacturing and the inability to delegate one’s regulatory obligations. Our recommendations remain the same.
  • Senior management must be involved. Ideally, management’s commitment to quality and compliance is demonstrated daily. However, mistakes can inevitably occur and, if they do, management must step up and lead. Mere reliance on others is insufficient.
  • Problems are compounded when management fails to show leadership and allows non-compliance to permeate the corporate culture. Negative FDA observational findings at multiple sites is never positive and, if not addressed thoroughly, can lead to court action, import alerts, or other significant actions that can, and will, significantly affect a company’s financial bottom line and its corporate reputation.