FDA WARNING_LETTER - Teahouse Tapioca and Tea Inc. - November 18, 2021

On November 8-18, 2021, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Teahouse Tapioca and Tea Inc. in Houston, TX, following a previous inspection on May 8, 2019. The inspection found the company non-compliant with 21 CFR part 1 subpart L and section 805 of the FD&C Act, specifically for imported products like Mango Powder Mix, Green Apple Syrup, and Medium Tapioca.

The primary violation is the failure to develop, maintain, and follow an FSVP for any imported food products. The company acknowledged not having an FSVP Plan and proposed a November 2022 timeline to implement one, including FSPCA training and third-party assistance. However, the FDA deemed this response insufficient due to a lack of specific tasks, responsible parties, and documentation of corrective actions.

Failure to adequately address these violations may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. Teahouse Tapioca and Tea Inc. must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation, and explaining any delays.