Samuel Tamez
President and Co-Owner
Productos Bredy USA LLC
7601 North Loop East
Houston , TX 77028-6017
United StatesFEI 3008496888Issued Aug 3, 2021Division of Southwest 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 3008496888.
Violations1
Issue DateAug 3, 2021
Product TypeOther
StatusOpen
Letter Details
Firm
Productos Bredy USA LLC
Location
Samuel Tamez
President and Co-Owner
Productos Bredy USA LLC
7601 North Loop East
Houston , TX 77028-6017
United States
FEI Number
3008496888
Country
United States
Issue Date
August 03, 2021
Issuing Office
Division of Southwest Imports
Product Type
Other
Status
Open
Summary
Productos Bredy USA LLC, a food and beverage importer based in Houston, Texas, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for any of its imported products, including soft drinks from a foreign supplier, in violation of Section 805 of the Federal Food, Drug, and Cosmetic Act. Despite registering for FSVP training and committing to develop the program following an initial inspection in September 2018, the company had not created an FSVP for any imported products by the time of the March 2021 reinspection and did not respond to the FDA 483a observations issued at the conclusion of that inspection. The company's failure to implement risk-based supplier verification activities meant its imported foods could not be verified as meeting applicable U.S. food safety standards.
Productos Bredy USA LLC FDA Warning Letter, August 3, 2021