FDA WARNING_LETTER - Zhao Qing Longda Biotechnology Co. Ltd. - September 26, 2023

The FDA issued a Warning Letter to Zhao Qing Longda Biotechnology Co. Ltd. (FEI 3014354419), a manufacturer of OTC drug products, including children's toothpaste, in China. The firm's registered drug ingredients are susceptible to Diethylene Glycol (DEG) and Ethylene Glycol (EG) substitution.

The FDA initiated an electronic request for records under section 704(a)(4) of the FD&C Act on March 17, 2023, which went unanswered. Subsequent requests on April 6 and April 18, 2023, also received no response. On April 19, 2023, the firm stated it was "not prepared to allow the FDA to audit and inspect." A follow-up written request on April 28, 2023, failed delivery.

Refusal to permit access to records as required by section 704(a) is a prohibited act under section 301(e) of the FD&C Act. Due to the firm's failure to respond, the FDA has no indication of the quality assurance for drugs manufactured there, especially concerning DEG/EG contamination risks.

As a result, the FDA may withhold approval of new applications listing the firm as a drug manufacturer. Shipments from the firm are subject to detention or refusal of admission under section 801