FDA WARNING_LETTER - Saad Trading Inc. - September 21, 2021
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
On January 11, 2022, the FDA issued a Warning Letter to Saad Trading Inc. following Foreign Supplier Verification Program (FSVP) inspections conducted from August 18 to September 21, 2021, and previously in March 2021. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.
The March 2021 inspection was prompted by an FDA sample finding of *Salmonella* in plain halva imported from foreign supplier (b)(4). This led to the voluntary destruction of the product and the foreign manufacturer being placed on Import Alert 99-19.
The recent inspection found Saad Trading Inc. not in compliance with FSVP requirements for plain halva from (b)(4), tahina from (b)(4), and dried okra from (b)(4). Significant violations include: 1. Failure to promptly investigate and document the adequacy of the FSVP, and modify it, after the *Salmonella* finding in plain halva (21 CFR 1.508(b)). 2. Failure to document review and assessment of hazard analyses from foreign suppliers for tahina and halva, or that this was done by a qualified individual (21 CFR 1.504(a), (d)). 3. Failure to document evaluation of foreign
ID · 834fa30d-a490-434f-8e04-4b0fc8e6c352
Full citation text and observation details available on the Dashboard.