Stepan Company – FDA EIR, Mar 4, 2022

An FDA surveillance inspection of Stepan Company in Northfield, IL, was conducted from March 1-4, 2022. This initial inspection focused on the company's compliance with the Foreign Supplier Verification Program (FSVP) for imported food products, specifically Clarinol G-80, Clarinol Powder, and Kola Nuts.

The inspection identified several significant violations. A primary finding on FDA Form 483a was the absence of developed FSVP plans for Clarinol G-80 and Clarinol Powder (21 CFR 1.502(a)). Further issues included a lack of written hazard analyses for these same products (21 CFR 1.504(a)). For Kola Nuts, the firm failed to adequately document the application of appropriate controls for microbiological hazards, as their HACCP plan contradicted their stated procedures (21 CFR 1.507(a)(1)). Additionally, documentation for foreign supplier verification activities was insufficient, with only audit certifications provided instead of comprehensive audit paperwork (21 CFR 1.506(e)(1)(iv)(B)), and there was a lack of documented approval for a specific foreign supplier (21 CFR 1.511(c)(1)).

Stepan Company's management acknowledged the observations and committed to providing the missing documentation and integrating necessary information into their FSVP plans. All objectionable conditions were noted as "Not Corrected" at the time of the report, indicating that the company must implement corrective actions to comply with FDA regulations.