FDA WARNING_LETTER - Aroma Imports, Inc. - August 26, 2021

On August 5-26, 2021, the FDA inspected Aroma Imports Inc. for compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L). A previous inspection occurred on December 18, 2020. The company was found not in compliance with FSVP requirements, violating section 805 of the FD&C Act. A Form FDA 483a was issued, but no response was received.

Significant violations include: 1. Failure to obtain written assurances from foreign suppliers for imported foods (e.g., Ajwa dates, tahina) before import and every two years thereafter, as required by 21 CFR 1.512(b)(3) for very small importers. 2. Failure to document appropriate corrective actions after being notified of an adulteration issue (Salmonella contamination) with a foreign supplier of halawa, as required by 21 CFR 1.512(b)(4). Despite a previous shipment being destroyed due to Salmonella and the supplier being on Import Alert #99-19, the company re-imported halawa from the same supplier without documented corrective actions.

The FDA also noted that while the company claims "very small importer" status, they did not provide annual documentation of this eligibility as per 21 CFR 1.512(b)(1)(i).