Chinese OTC Firm Warned for Testing Violations
The FDA issued a warning letter to OTC drug manufacturer Ningbo Pulisi Daily Chemical Products in Zhejiang, China for testing violations, including failure to fully test products prior to release.
An agency inspection revealed that the facility did not conduct identity testing for all ingredients or microbial testing for each product batch.
The firm also failed to adequately test incoming raw materials to ensure they met specifications for identity, purity, strength and quality. Raw materials were assessed based only on smell and appearance, the investigators found.