FDA EIR - Xinfa Pharmaceutical Co., Ltd - April 07, 2016

An FDA inspection of Xinfa Pharmaceutical Co., Ltd in Dongying, China, was conducted from April 5-7, 2016, focusing on the company's manufacturing of dietary supplement and animal feed ingredients like Riboflavin. The inspection evaluated compliance with domestic food safety regulations and Good Manufacturing Practices (GMPs).

The inspection resulted in a Form FDA 483, Inspectional Observations, issued to owner Mr. Xinfa Li. Key violations included a failure to adequately clean and sanitize food-contact surfaces, specifically Riboflavin tanks, filters, and sieves, which showed product residue even after cleaning and quality control release. Additionally, the inspection noted inadequate lighting in manufacturing areas, particularly in the Riboflavin workshop, hindering proper assessment of equipment conditions.

Verbal deficiencies also highlighted issues such as insufficient hand-washing facilities (which were corrected during the inspection), unscreened gaps in warehouse doors, and harborage areas with unused equipment and uncovered garbage bins (corrections in progress). Mr. Li acknowledged the findings and committed to implementing corrective actions. He also agreed to provide a written response to the FDA 483 observations within 15 business days. The FDA investigator also offered recommendations for improving the Certificate of Analysis, implementing continuous temperature and humidity monitoring, maintaining legible records, and utilizing the most current USP methods for laboratory testing.