Jost Chemical Co. – FDA EIR, Oct 13, 2023

An FDA inspection of Jost Chemical Co., an Active Pharmaceutical Ingredient (API) manufacturer in Saint Louis, MO, was conducted from October 10-13, 2023. This was a directed current Good Manufacturing Practice (cGMP) and follow-up inspection to a previous Warning Letter, guided by CPGM 7356.002F for API inspections and ICH Q7. The inspection identified two significant observations documented on an FDA Form 483. The first concerned inadequate investigation records for critical deviations and out-of-specification batches. Specifically, an investigation into Zinc Citrate Dihydrate USP contamination with Aspergillus flavus/oryzae lacked a determined root cause, and the firm failed to conduct comprehensive expanded testing of associated batches. The second observation highlighted equipment design deficiencies, noting air gaps in Fluid Bed Dryers that allowed direct ingress of external environmental contaminants into product pathways, posing a risk given the firm's history of microbiological failures. Verbal observations also included incomplete investigation information, delayed implementation of corrective and preventive actions (CAPAs), and a practice where initial failing in-process test results were retested without proper Quality Assurance review, with only passing retest results attached to batch records. Management committed to providing a written response to the FDA 483 observations within 15 business days, with specific commitments including reviewing in-process test logs and expanding investigations to entire product campaigns when appropriate.