In a series of regulatory wrist-slaps now made public, the FDA has taken three manufacturers to task over record request breakdowns.
The FDA disclosed separate warning letters to China-based active pharmaceutical ingredient (API) manufacturers Tianjin Healthcare Medical Technology (THM) and Chongqing Qiancan Technology (CQT) this week. In both cases, the companies, which were shipping drug ingredients for compounding to the United States, failed to honor the regulator’s requests for information.
The incidents led the FDA to place all U.S.-bound drugs and products from the two companies on import alert earlier this year.
The FDA first sent a record request to THM on June 17 after discovering multiple API shipments to the U.S. for pharmacy compounding that had THM declared as the manufacturer. The company responded a week later that it would “‘discontinue the production” of the relevant products for the U.S., though it nevertheless “refused to provide requested documents,” according to the FDA.
The FDA followed up with another request a day later, noting that drug ingredients THM manufactured and shipped to the U.S. were still within expiry, meaning the company still needed to provide the information.
But the company again refused, with the FDA stressing in its write-up that “[s]imply ceasing commercial distribution or expressing an intent to stop production does not retroactively relieve you of your regulatory obligations.”
It was a similar situation at CQT, which the FDA also contacted with an initial record request on June 17 after noting prescription compounding API imported to the U.S. that listed the company as its manufacturer.
In response, CQT “de-registered and discontinued your drug listing on June 29, 2026, one day prior to your reply on June 30,” according to the FDA. In that follow-up, CQT told the FDA it could not meet its record request requirements.
“The requested records were never provided despite APIs manufactured by your firm being imported to the U.S. market and still being within expiry,” the FDA explained, adding that CQT also re-registered on July 13.
Both companies’ products were placed on import alert in late August.
Another China-based API manufacturer, Hanxin Pharmaceutical Technology, was also dinged in a warning letter issued earlier this month over lapses within its quality unit, which the FDA noted in a review of records the company submitted. Hanxin’s facility in question is registered with the FDA as a manufacturer of API used to make sterile drugs and for pharmaceutical compounding.
Based on the records Hanxin did initially provide, the company’s quality unit failed to properly qualify suppliers of critical raw materials used to manufacture certain drug ingredients, the FDA explained.
The FDA subsequently requested additional quality records on drugs produced by Hanxin, though the company did not comply and, upon further request, told the FDA it had shifted production of certain products to another subsidiary.
Hanxin’s warning letter was heavily redacted, though the FDA added that the company lists various APIs under its manufacturer registration that weren’t referenced in its response to a prior FDA record request. The FDA specifically pointed out that one undisclosed product “is not an API permissible for use in human drug compounding.”
The FDA added it was “concerned” that Hanxin may have been misidentifying itself as the manufacturer of certain ingredients in an effort to “circumvent safeguards,” which could pose a risk to patients who receive drugs made with those API.
The agency placed all U.S.-bound drugs and products from the company on import alert as of June 22.