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Communication Key in Client's Response to FDA

Key Facts

  • Client develops and manufactures innovative medical technologies for facility and home-based medical care
  • The company has international operations in multiple countries
  • The client has two open inspections, but a warning letter has been avoided

The Situation

Our client received an FDA inspection report identifying extensive observations. Despite system-wide corrective actions, the company received additional observations in a recent FDA inspection. The FDA continues to work the company through a detailed, voluntary corrective action plan based on extensive reporting and communication.

The Approach

Mintz immediately recognized the need for a corrective action plan that looked holistically at quality system deficiencies rather than focusing only on the narrow scope of the observation. The company’s commitment to extensive restructuring of important areas, like complaint handling and CAPA, engendered a relationship with the FDA that is permitting this more extensive corrective action approach. Our team is intimately involved in implementing the corrective actions through drafting new procedures and on-site training and evaluation that reinforce the corrective actions. Mintz provided on-the-ground support during the follow-up inspection and leads the strategic communication with the FDA.

The Outcome

The company received a request from the FDA for an in-person Regulatory Meeting, rather than a warning letter. Mintz continues to work with the company to structure and implement extensive corrections to the quality system.

Supporting Professionals

Benjamin Zegarelli assisted in coordinating the client's response to the FDA.