ISP Chemicals LLC – FDA EIR, Jan 10, 2019

An FDA surveillance inspection of ISP Chemicals LLC in Calvert City, KY, was conducted from January 7-10, 2019. The inspection, performed under Compliance Program 7356.002F for Active Pharmaceutical Ingredient (API) process inspections, focused on the company's manufacturing of Povidone Iodine, USP. The review covered quality, materials, production, packaging & labeling, and laboratory control systems, with partial coverage of facilities & equipment.

While no FDA Form 483 was issued, several deficiencies were verbally discussed with management. These included the absence of retest dates on product labels, despite additional labels being printed for specific customer requests. Significant issues were identified within the deviation management system, such as a lack of formal procedures for deviations not related to the production process, insufficient justification and assessment in process deviation documentation, and missing root cause analyses for corrective actions. Furthermore, one complaint investigation was not initiated promptly, and the corresponding supplier's response was not included in the investigation records.

ISP Chemicals LLC management acknowledged these observations and committed to implementing corrective measures to address the identified issues. The company's drug establishment and food facility registrations were noted as current.