FDA WARNING_LETTER - Global Commodities Corp. - February 27, 2020

On June 3, 2020, the FDA issued a Warning Letter to Global Commodities Corp. following a follow-up Foreign Supplier Verification Program (FSVP) inspection on February 27, 2020, and an initial inspection on September 12, 2017. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L.

The firm was found non-compliant for not having FSVPs for Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup preserves from (b)(4), Philippines, and Boy Bawang Mixed Nuts Snacks – Garlic from KSK Food Products, Philippines.

Specific violations include: 1. Failure to develop, maintain, and follow an FSVP for Boy Bawang Mixed Nuts Snacks-Garlic (21 CFR 1.502(a)). 2. Failure to verify and document that low-acid canned foods (Buenas Kaong Red Sugar Palm Fruit in Syrup and Macapuno String in Syrup Preserves) were produced in accordance with 21 CFR part 113, or to otherwise develop an FSVP for matters not controlled by part 113 (21 CFR 1.502(b)(1)).

The firm's March 5, 2020, response, including a HACCP plan and SGS