FDA warning letter · Drugs

Sangleaf Pharm., Co. Ltd.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

This request went unanswered. A second request was sent via e-mail on January 11, 2023, followed by an attempted contact by telephone with your registered U.S. Agent on January 26, 2023, regarding this matter. The Agency sent a follow-up written request for such records and other information on January 27, 2023. Delivery to you was confirmed by the shipper, but you failed to respond to these attempted communications or otherwise provide the requested records or other information.