The U.S. Food and Drug Administration (FDA) notified the site, of a planned inspection of the drug manufacturing facility from September 18 to 22, 2023.
On May 23, 2023, the FDA sent an electronic notice of inspection to the contact email address provided in the registration file of the site.
This request went unanswered, as did the second and third email requests sent on June 6 and 21, 2023, respectively.
An FDA representative then attempted to contact the firm's U.S. Agent on August 25, 2023.
A fourth email attempt to contact the firm was sent on August 29, 2023, but firm failed to respond.
The Agency then sent a follow-up written request via UPS, that was delivered to the physical address provided in firm's registration file on August 29, 2023.
Delivery to the site was confirmed by the shipper, but firm failed to respond.
Under section 501(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(j), firm's drugs are adulterated in that they have been manufactured, processed, packed, or held in an establishment that delays, denies, or limits an inspection, or refuses to permit entry or inspection.
FDA placed the firm on Import Alert 55-03 on January 18, 2024.
Until FDA is permitted to inspect firm's facility and confirms compliance with CGMP, FDA withhold approval of any new applications or supplements listing the firm as a drug manufacturer.
In addition, shipments of articles manufactured at this site into the United States that appear to be adulterated or misbranded are subject to being detained or refused admission pursuant to section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
Not responding to USFDA request may not be the right choice.
Not responding to USFDA may not be the right communication.