FDA EIR - Ash Stevens LLC - November 02, 2015

This FDA pre-approval inspection of Ash Stevens Inc. in Riverview, MI, was conducted from October 28 to November 2, 2015. The inspection focused on the company's manufacturing processes for a specific active pharmaceutical ingredient (API), covering Quality, Production, Materials, and Laboratory Systems. It was performed under regulatory guidelines for API process and pre-approval inspections. Notably, the inspection concluded without any observations, and an FDA Form 483, detailing potential violations, was not issued to management. This indicates that, concerning the areas reviewed, the facility was found to be in compliance with Good Manufacturing Practices at the time of the inspection. While no new issues were identified, the report noted a previous inspection in 2014 resulted in one observation concerning the failure to review original electronic laboratory records. This specific item was not re-evaluated during the current inspection but was flagged for follow-up in a future assessment. The firm had also conducted internal investigations related to out-of-specification results for a product impurity, leading to a voluntary corrective action of implementing new raw material testing requirements. The lack of a Form 483 suggests a favorable outcome for this particular inspection regarding the API manufacturing readiness.