FDA EIR - APAC Chemical - August 13, 2021

An FDA remote initial inspection was conducted on APAC Chemical, located in Monrovia, CA, from July 26 to August 13, 2021. The inspection focused on the company's compliance with the Foreign Supplier Verification Programs (FSVP) for Human Foods, a critical regulatory framework ensuring the safety of imported food products.

During the review, three specific human food ingredients—Potassium Sorbate, Sorbic Acid, and Phosphoric Acid—were examined. The firm proactively provided a comprehensive FSVP Plan along with all requested supporting documentation for these products. Notably, the inspection concluded with no FDA 483a FSVP Observations being issued, indicating a satisfactory level of compliance with federal regulations.

Consequently, there were no main violations or issues identified during this inspection. The company demonstrated effective implementation of its FSVP, including thorough hazard analyses, foreign supplier evaluations, and robust verification activities. Management was advised to continue maintaining and developing their FSVP for all current and future imported products, underscoring the ongoing commitment to regulatory adherence and food safety standards.