Mr. Fernando Gallardo and Mr. Mario Gallardo
Owner & General Manager
Facema, LLC.
9385 Washington Blvd N., Suite H
Laurel , MD 20723
United StatesFEI 3002857670Issued Oct 18, 2022Division of Northeast Imports
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002857670.
Violations1
Issue DateOct 18, 2022
Product TypeOther
StatusOpen
Letter Details
Firm
Facema, LLC.
Location
Mr. Fernando Gallardo and Mr. Mario Gallardo
Owner & General Manager
Facema, LLC.
9385 Washington Blvd N., Suite H
Laurel , MD 20723
United States
FEI Number
3002857670
Country
United States
Issue Date
October 18, 2022
Issuing Office
Division of Northeast Imports
Product Type
Other
Status
Open
Summary
Facema, LLC., a food importer based in Maryland, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) as required by federal law for imported foods including tomato sauce, toffee candy, and peanuts. The company did not develop any FSVP documentation to verify that its imported foods met applicable U.S. food safety standards, representing a significant violation of 21 CFR part 1, subpart L. The violations were identified during an FDA inspection conducted from May through August 2022, and the company failed to respond to the FDA's Form FDA 483a observations issued on August 3, 2022.