FDA 483 - ISP Chemicals LLC - July 17, 2025

An FDA inspection conducted on July 17, 2025, at ISP Chemicals LLC, an Active Pharmaceutical Ingredient (API) manufacturer located in Calvert City, KY, identified two significant observations regarding their manufacturing and quality control practices.

The first observation noted a failure to utilize validated and stability-indicating test procedures for API. The company had not established a stability-indicating method within its stability testing program, failed to perform degradation studies for APIs, and had not identified potential degradation products in its finished API drug products. This indicates a potential risk to product quality and shelf-life assurance.

Secondly, the inspection found that the firm’s written procedures for API sampling plans and methods did not conform to established quality standards. Specifically, the sampling procedures for finished API drug products lacked scientific justification to measure batch variability. Samples were taken exclusively from limited areas of containers, rather than providing representative samples crucial for accurately assessing the quality of an entire batch. For instance, only a few samples were drawn from specific areas for large batches, a practice applied to approximately 50 lots of API drug products manufactured and released since July 2023.

These observations, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, highlight deficiencies that ISP Chemicals LLC must address to ensure compliance with regulatory requirements and maintain product quality and safety.