Friday, November 4, 2022

FDA Warning Letters Issued to Three Importers for Lack of FSVP - Nov 1 2022

Three importers were issued Warning Letters by FDA for lacking a FSVP for imported foods.

Facema, LLC
. of Laurel, MD did not develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any imported foods, including the following food:  Tomato sauce (with other ingredients) imported from (b)(4), located in (b)(4);  Toffee candy imported from Facema S.A. de C.V. located in Nicaragua; and 
Peanuts imported from (b)(4) located in (b)(4).
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/facema-llc-640528-10182022

ARYZ Trading, LLC of  Dearborn, MI did not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following foods:  Dried mint: imported from (b)(4)
Tahina: imported from (b)(4) Extra virgin olive oil: imported from (b)(4)
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/aryz-trading-llc-639322-09212022

Minuti Coffee Llc, of Houston, TXdid not develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). Specifically, did not develop an FSVP for any of the foods imported, including each of the following:  a. Hot Chocolate (Cioco Delice White Chocolate), imported from Caffe Molinari S.P.A., Via Francia 20, Modena, Modena, 41122, Italy b. Decaf Coffee and Vinegar, imported from Caffe Molinari SPA, Via Manfredo Fanti 200/206, Modena, Modena, 41122, Italy
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/minuti-coffee-llc-635961-08232022

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