Validant Case Study

Rapid Warning Letter Closure


When a European cosmetics manufacturer received a Warning Letter on its sunscreen drug product, which represented less than 2% of factory throughput, the company knew installing GMP would not be economical solution. Therefore, outsourcing was needed and they turned to Validant for support.


Validant deployed a team with local language skills to:

  • Perform a holistic Quality System assessment, including for Investigations, OOS, and Complaints
  • Lead drug product outsourcing
  • Institute an Interim Control Plan for batches produced until transfer
  • Build a Quality System consistent with the new outsourcing model

With Validant’s hands-on guidance and boots-on-the-ground execution, the European OTC manufacturer:

  • Avoided large site-wide remediation saving over $5M in costs.
  • Quickly determined CMO/CLO while minimizing client resources.
  • Demonstrated operational control in the interim resulting in Warning Letter closure.

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