FDA EIR - ISP Sutton Laboratories - July 27, 2016

An FDA inspection of Ashland Specialty Ingredients in Chatham, NJ, was conducted from July 26-27, 2016. The inspection, focusing on the company's manufacturing of active pharmaceutical ingredients (APIs) and intermediates, adhered to guidelines for API process inspections and verified adherence to Current Good Manufacturing Practices (cGMP). Notably, no FDA Form 483 (Inspectional Observations) was issued during this inspection, indicating general compliance. However, a key discussion with management centered on the firm's temperature monitoring practices for its manufacturing and warehouse areas. While temperatures were monitored, routine checks and records for product storage conditions, particularly for APIs like Allantoin with specific limits, were not consistently performed. Management committed to implementing more frequent and consistent temperature monitoring as a voluntary correction. The inspection also reviewed the firm's successful voluntary corrective actions stemming from a prior 2013 inspection. These included establishing clear alert and action levels for facility water microbiological data, ensuring investigations into out-of-specification results, and adjusting batch yield specifications for Allantoin based on process validation. Furthermore, the company enhanced its laboratory chromatography data systems by implementing individual user access controls, restricting administrative privileges, and developing robust data integrity, security, and backup procedures. Overall, the company demonstrated a strong effort in resolving previous compliance issues.