FDA Slams Huangshi Hygienic Material Medicine in Warning Letter
June 7th, 2025 // 12:48 pm @ jmpickett
Huangshi Hygienic Material Medicine Co., a maker of OTC drugs in Huangshi City, China, received a warning letter in June 2025 for various cGMP violations. One of the most critical was failure to test products before their release (21 CFR 211.165(a)) as well as failing to affix the current expiration dates on products.
FDA states that Huangshi didn’t test products, including the strength and identity of each API, before they were released. FDA states in the warning letter that the company must perform full release testing for identity, strength, and purity. It must be done before batch release and distribution. Without sufficient product release testing, there isn’t sufficient scientific basis that each drug product batch conforms to specs before release.
In the company’s response, it said that exported products are made using the same processes and formulation as domestic standards. So, the internal quality standards for products to be exported are based on those for domestic sales products, which do not need testing for quantity or identity of APIs.
This was deemed inadequate by FDA because the company said that internal quality standards and SOPs for export products would be revised to have the identity or quantity of APIs. Both of these must be tested before the drug products are released. The company did not assess the risk of drug products sent to the US without proper testing. The company also did not discuss its plan to do validation of test methods.
The Chinese OTC manufacturer also failed to put the proper expiration dates on product labeling. Expiration dates were assigned according to stability testing done in China, without taking into consideration that formulations for products for the US market are different than those for domestic products.
Keep in mind during FDA inspections that inspectors may review your import records. To pass your audit and avoid a warning letter, make sure that full release testing has been done, including strength and identity testing of APIs in finished products before release.
