In a warning letter posted online on Nov. 7, FDA said that its investigators found violations of current good manufacturing practices (cGMPs) at the company's facility in Zhangjiang City, Guangdong Province. The drug products made at the facilities are considered adulterated under the Federal Food, Drug and Cosmetic Act, the agency said.
Warning letters are a good indication of FDA's enforcement priorities.
The company did not test the identity and strength of active ingredients in drug products before distributing them, FDA said.
Also, the agency said the company lacked an ongoing program of monitoring process controls to ensure stable manufacturing operations and consistent drug quality.
One of the products the company manufactures is a topical over-the-counter drug product labeled as containing the active ingredient hydrocortisone, the letter said. During FDA's inspection, its investigators reviewed records showing that the active pharmaceutical ingredient actually used in the product was dexamethasone acetate. This product was recalled in August 2017, but the company has not given FDA details on its plan to prevent a recurrence of this issue.
FDA also said the company has not provided details of an evaluation to ensure all of its drug products released for distribution to the U.S. were manufactured with appropriate components.
Because of these issues, FDA placed the company on an import alert on Aug. 21.
FDA asked the company to correct the violations and respond to the warning letter.
Until all violations are corrected, the agency may withhold approval of any new applications or supplements listing the company as a drug manufacturer, the letter said. The agency also said failure to correct the violations may result in FDA continuing to refuse admission of products made by the company into the U.S.
The warning letter was signed by Francis Godwin, acting director of FDA's Office of Manufacturing Quality.
The company could not be reached for comment on the warning letter.
Read more in the FDA warning letter.
Selected information in the "Pharmaceutical Science Update" is compiled from summaries and articles from Bloomberg BNA.