FDA 483 - Zochem ULC - July 20, 2023

During an FDA inspection conducted from July 17 to July 20, 2023, the firm received a Form FDA-483 document detailing two significant observations related to its quality system for raw material management. The first observation concerned the firm's practice of accepting raw material supplier analyses. The FDA noted that the company failed to establish the reliability of supplier analyses through appropriate validation. Specifically, while the firm performs in-house testing intended to validate supplier Certificates of Analysis (CofA), these results were incorrectly compared against the firm’s own specifications rather than directly against the supplier’s CofA results. This practice compromises the assurance of raw material conformity. The second observation highlighted deficiencies in the firm's supplier qualification process. A new raw material supplier in 2022 was approved without a required supplier audit questionnaire, and was added to the approved vendor list before necessary material qualification testing, contrary to the firm’s written procedures. Furthermore, there was no documented assurance that the approved vendor list is consistently confirmed prior to placing raw material orders. These observations indicate potential non-compliance with quality system requirements for raw material control and supplier management. The firm is required to address these findings by implementing corrective actions and is responsible for conducting internal self-audits to ensure full adherence to quality system regulations.