STPCA Inc. dba Sun Ten Laboratories
FDA issued a warning letter to STPCA Inc. dba Sun Ten Laboratories (Irvine, CA) following a facility inspection and website review, finding that eight products (Yi Min, Jian Shen, Yu Zhi, Xiao Yan, Qu Yu, Yi Jun, Platcladus Leaves Ce Bai Ye, and Shu Jin 2) were marketed with disease-treatment claims that rendered them unapproved new drugs under the Act. The agency also cited serious CGMP violations for dietary supplement products (Lycium Formula Huan Shao Dan, and two redacted products), including failures in identity specifications, quality control disposition decisions, and master manufacturing records. Additionally, multiple products were found misbranded due to labeling deficiencies including foreign-language label requirements, missing plant-part identification, and non-compliant Supplement Facts panels. FDA demanded written corrective action within 15 working days and warned that failure to comply could result in seizure or injunction.
Flagged claims (8)
Reduce urinary tract infections symptoms
Improve… low blood sugars
Aids in stopping bleeding
Relief of allergy related symptoms
Relief of inflammation and fungal infection
Support trauma injury relief
Relief of pain and stiffness in the lower body
Relief of hemorrhoids conditions and constipation
Required actions (3)
Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
Failure to adequately address this matter may result in legal action including, without limitation, seizure, and injunction.
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