OTC Pharma Warning Letter Response Assistance

Client Business Situation

This client company was a long-established, family-owned, manufacturer of dietary supplements and OTC pharmaceuticals, with a long, and unfortunately poor history of compliance with the US FDA. The company had also been experiencing problems with customer fulfillment and product quality.

Client Business Pain

After a particularly aggressive FDA inspection, the client received a significant FDA Warning Letter that covered both Quality Systems’ deficiencies and unapproved product marketing activities. The Agency’s letter advised the client to respond within 20 days of receipt of letter. Client had very little experience with FDA enforcement actions, and had always responded to FDA 483 observations without further communication from FDA. In this case, the 483 response was insufficient given the FDA’s enforcement approaches at the time.

Solutions Provided/Services Delivered

In a short engagement, Compliance Architects®:

  • reviewed the entire documented enforcement history and compliance enforcement communications;
  • reviewed and assessed both systemic gaps and physical plant gaps for remediation needs; and
  • developed a remediation action plan overview, with timing, and an order-of-magnitude estimate of the costs to resolve the enforcement gaps and deficiencies.

Unfortunately, upon a detailed review of the costs and timing associated with the core remediation program, and due to the client’s lack of available client capital, the client needed other options. Upon a further review of the goals of the family-business leadership, and due to the extremely poor enforcement history of the company, and the significant capital costs that would be necessary to improve the physical plant, it was determined the best approach would be to voluntarily discontinue the manufacture of pharmaceutical OTC products through self-enjoinder and self-seizure and focus on the dietary supplement product manufacturing until such time as proper funding could be made available to finance remediation activities.

Benefits Realized

The innovative solution provided by Compliance Architects®, while unusual, allowed this family-owned company to continue some manufacturing operations, and keep a core of clients and revenue in place until such time as the company was ready to commit further capital. Further, this allowed the company to begin development of remediation plans, on a slower, self-guided scale, that brings them closer to their goal of OTC Pharmaceutical market re-entry.

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