FDA EIR - Integrated Commercialization Solutions, Inc. - January 18, 2018

Integrated Commercialization Solutions, Inc. underwent an FDA surveillance inspection from January 16-18, 2018, focusing on its Reno, Nevada warehouse and distribution operations for both over-the-counter and prescription drug products. The inspection evaluated the firm's chain of custody for drug products stored under various controlled temperatures, written procedures for receipt, storage, and distribution, as well as pest control and general Good Manufacturing Practice (GMP) requirements. The primary issue identified resulted in one FDA Form 483 observation: inadequate control over temperature-monitoring equipment for drug product storage. Specifically, critical temperature probes meant to monitor the warmest and coldest locations within the Controlled Room Temperature (CRT) warehouse were found to be missing, contradicting the firm's recent Performance Qualification report. This deficiency relates to the regulatory requirement for providing adequate temperature control equipment where appropriate for holding drug products (21 CFR 211.46(b)). In response, the company’s management acknowledged the oversight. The Quality Manager promptly arranged for the missing probes to be installed in the identified locations during the inspection. The company committed to providing a written response to the FDA detailing its corrective actions within 15 business days. No samples were collected, and no other refusals or major issues were noted.