Chinese OTC Drugmaker Warned for Quality Failures, Missing Data

The FDA cited Sunstar for serious violations at a manufacturing facility in China, issuing the firm a warning letter for failing to test incoming drug components and finished products, among other violations.

Sunstar’s Guangzhou facility, which manufactures over-the-counter drug products, released product batches without conducting identity and strength testing, the agency found in a June 24-28, 2019 inspection.

In its response to the inspection findings, the company said it would begin sending all batches to the lab for analysis prior to distribution. But the agency found the response inadequate because the company did not say it would test all reserve samples of drug products containing the cited active ingredients to ensure they met identity and strength specifications.