The FDA did not buy a manufacturer’s rationale that its quality lapses are due to different Chinese standards, resulting in a warning letter for a slew of violations.

During a March inspection of China Resources Sanjiu Medical and Pharmaceutical’s Shenzhen, China, facility, the FDA found the drugmaker doesn’t fully test active pharmaceutical ingredients (APIs) for certain products.

The company’s products — Ganmaoling Cold Granule and Ganmaoling Cold Capsule — contain acetaminophen, chlorpheniramine maleate and caffeine. China Resources, however, only tests acetaminophen for quality before a batch is released, according to the letter.

The manufacturer responded that it abides by the Chinese National Legal Standard, which only requires testing for acetaminophen. However, since the products are intended for the U.S. market, the company must meet FDA standards that call for extensive quality testing of all APIs, the agency said.

In addition, investigators discovered the manufacturer hadn’t created a release specification and test procedure to determine impurities in Ganmaoling Cold Granule and Ganmaoling Cold Capsule products. China Resources said it could not separate the APIs and impurities effectively due to the products’ complicated formulation.

China Resources also doesn’t test chlorpheniramine maleate and caffeine for stability, the FDA said.

The agency said China Resources must submit specifications, testing methods and data for purity, impurity, release and stability for any product marketed in the U.S.

The letter also dings the drugmaker for not fully registering its facility with the FDA. In 2013, China Resources moved to another site in Shenzhen but failed to register it with the agency as a manufacturing facility.

China Resources was put on import alert by the FDA on Sept. 3, effectively barring the drugmaker from shipping products to the U.S.

The manufacturer did not return a request for comment as of press time.

The warning letter can be accessed at www.fdanews.com/10-14-14-ChinaResourcesWarning.pdf. — Robert King