Jing Cheong Asia Inc. dba New York Tong Ren Tang
2 extracted findings
FDA source excerpt, selected passage
“Ofloxacin Eye Drops,” “Jingzhi Niuhuang Jiedu Pian,” and “Gui Pi Wan” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
“Ofloxacin Eye Drops,” “Jingzhi Niuhuang Jiedu Pian,” and “Gui Pi Wan” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a).
Source passage selected by the model
02
Previous FDA lab analyses of the product similarly named to “Notoginseng Formula Special Gout Granule” sold on your website revealed the product contained undeclared drug ingredients.
Source passage selected by the model
Sections and clauses cited
As cited in this historical letter, not a statement of current regulatory requirements.