A California bakery and a New York seafood importer are both on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act.

The FDA sent the warning letters to the companies in May and July, and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters. Failure to promptly correct violations can result in legal action without further notice, including, without limitation, seizure and injunction.

The Cookie Boys San Jose, CA
In a May 3 warning letter to company owner and president Jeffrey M. Heilman, the FDA described violations observed during an inspection on Sept. 20,21 and 22, 2016, at The Cookie Boys bakery in San Jose, CA. The company manufactures cookie products at the bakery, according to the warning letter.

All people working in direct contact with food, food-contract surfaces and food-packaging materials are required by federal law to comply with the current Good Manufacturing Practice (cGMP) Regulations.

The FDA inspector noted several significant violations. First was failure to ensure that everyone working in direct contact with food, food-contact surfaces and food-packaging materials conformed to hygienic practices to the extent necessary to protect against contamination of food.

“Specifically, an employee was observed touching non-food contact surfaces, such as the oven door handle, cleaning bucket and a door handle without washing or sanitizing hands and proceeded to handle cookie dough with bare hands,” according to the warning letter.

“When washing hands, the same employee was observed cracking eggs, then touching the faucet to turn on the water to wash hands, touching the faucet to turn off the water with washed hands and proceeded to handle cookie dough with bare hands, which can contribute to cross contamination following the wash.”

The FDA warned that thorough hand washing is necessary to protect food against contamination with microorganisms.

Also noted, the bakery’s cookies were observed sitting on cooling racks overnight, unprotected and open to the environment, to air dry during non-production hours in an area accessible to non-production personnel. Furthermore, the bakery failed to adequately clean and sanitize cooling racks between uses to avoid cross contamination with products containing peanuts. Cookies made with peanut products were also observed being held in close proximity to other products, creating the potential for cross contamination with allergens that will not be declared on the labels of each finished cookie product.

Labeling issues were also a significant violation observed during the FDA inspection. The bakery’s cookies failed to declare the presence of color additives. The FDA “requires that the color additive be listed by that name in the ingredient list on the labels of foods for human use,” according to the warning letter.

The FDA also noted that the bakery’s “Iced Shortbread Cookies,” “Oatmeal Butterscotch Cookies” and “Chocolate Chip Cookies w/Walnuts” were misbranded for failure to declare a label containing the name of the manufacturer, packer or distributor, failure to declare the net quantity of contents, failure to declare the allergens in the ingredient statement, and failure to declare the place of business.

Furthermore, the FDA noted that the company’s website states, “The Cookie Boys have become … FDA approved!” The FDA does not approve food manufacturers, therefore this is a false statement.

Sinosharp Import & Export Co. Ridgewood, NY
In a July 12 warning letter to president and CEO Mr. Wei Song, the FDA cited serious violations of the seafood Hazard Analysis and Critical Control Point (HAACP) regulation at the seafood importer’s operation in relation to its ready-to-eat codfish fillets.

Inspectors discovered that the importer’s ready-to-eat baked codfish fillets, intended to be distributed at ambient temperature, had not been verified as being produced in conditions that comply with U.S. food safety regulations and standards.

The FDA discovered and documented problems at the Ridgewood, NY, facility on April 25 and 26. They found that the firm did not perform an affirmative step to ensure all of their fish or fishery products had been processed in accordance with the seafood HAACP Regulation.

The importer’s response letter to the FDA, dated May 1, included an annual certificate referred to as, “the HACCP Verification Certificate by the Certification and Accreditation Administration of the People’s Republic of China (CNCA), issued on 2017/1/18,” but the  list of products covered by the certificate did not include cod or baked cod fillets.

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