FDA Warns Chinese Drugmaker for Lax Microbial Testing

The FDA issued a warning letter to an active pharmaceutical ingredient and over-the-counter drug manufacturer in the Chinese port city of Guangzhou for releasing products without performing microbial tests.

The Guangzhou Tinci Materials Technology facility northwest of Hong Kong was taken to task for failing to test a product batch for the total aerobic microbial count as well as total yeast and mold counts.

The FDA placed the company on an import alert in November 2019 based on violations observed during a July 2019 inspection. The agency’s investigators found a production system had multiple dead legs that could allow biofilms to form. The system also had corroded pipes, brackets, fittings, valves and tanks.