FDA 483 - SpecGx LLC - October 22, 2025

An inspected facility in Lenexa, KS, received an FDA Form 483 on October 22, 2025, outlining significant observations from a recent inspection. The document, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, identified two primary areas of concern related to manufacturing practices. First, the facility's specifications for Active Pharmaceutical Ingredients (APIs) were found to be inadequate. Specifically, a non-sterile API product (material code: MM) did not include testing for Burkholderia cepacia complex (BCC), indicating a gap in ensuring product quality and safety consistent with accepted standards. Second, the inspection revealed that processed water systems, crucial for manufacturing APIs, were not regularly monitored to ensure their validated state. This lack of a consistent monitoring schedule raises concerns about the ongoing quality and suitability of the water used in production. To address these findings, the facility is expected to implement corrective actions. These actions would include establishing comprehensive testing protocols for APIs, incorporating all necessary microbial analyses, and developing a robust, regularly scheduled monitoring program for all water systems used in manufacturing to ensure their consistent quality and validated status, thereby upholding Good Manufacturing Practices.