A seafood warehouse and distribution facility in St. Croix and a bakery and central kitchen facility in Ohio are the latest targets of Food and Drug Administration (FDA) warning letters.

Recently released, a March 11 warning letter went to St. Croix on Virgin Island where the Merchants Market St. was found with serious violations of the seafood Hazard Analysis and Critical Control Point regulations. And earlier on Feb. 5, La Marquise inc., located in Upper Arlington, OH, received its warning letter over serious violations of Current Good Manufacturing Practice, HACCP, and Risk-based Preventive Controls for Human Food.

That letter says that during its inspection of the Ohio bakery and central kitchen, FDA found that food manufactured in the facility is “adulterated” within the meaning of the Federal Food, Drug, and Cosmetic Act. FDA says the food is adulterated” because it ” was prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.”

“At the conclusion of the inspection, FDA issued a Form FDA 483, Inspectional Observations, listing deviations found at your firm,” the warning letter says. ” However, to date, we have not received a response to these inspectional observations.”

FDA says La Marquise “must identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by your facility will not be adulterated.”

Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system

FDA is concerned about such inspection observations are these:

  • a stainless-steel mixing bowl with rough welds and dents on the inside of the bowl, which make it a surface that is not easily cleanable and that can harbor pathogens or allergen-containing food debris. The bowl was used on June 5, 2018, to mix dough for eclairs.
  • Dust build-up was observed on the fan covers of the cooling unit in the quiche freezer, dairy cooler, pastry cooler, and bread freezer. The finished product was stored uncovered in these coolers and freezers.
  • Dust build-up was observed on the blower vent of the air conditioning unit. Racks of bread were stored below the vent to cool.
  • Dust build-up was observed on the air filter bracket above the rotary oven and retail prep area. Clean pots and containers were stored below this filter.
  • Dust build-up was observed on electrical cords and electrical outlets directly above the pastry prep table.
  • An employee was observed not wearing a beard net while placing fruit on top of fruit tarts. Additionally, the employee’s shirt was touching some of the tarts.
  • An employee was observed wearing jewelry (a bracelet made of string) while making bread dough.
  • Employees’ personal items, including coffee cups and shake containers, were stored under prep tables in the manufacturing areas. An employee was observed taking a drink of the coffee stored under the prep table and then continued prepping pastries without washing their hands.
  • An employee was observed filling eclairs with cream. When the employee was handed their cell phone, which was found on the floor, the employee placed the cell phone in their back pocket and continued to fill eclairs with cream, without washing their hands.
  • An employee was observed loading a truck for delivery. The employee entered the building and removed a tray of desserts from the pastry cooler. The employee then picked up a cake from the tray, touched the cake with his fingers, and placed the cake into a box. The employee did not wash their hands before touching the cake.
  • You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur, ” the warning letter adds. “Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.”

In the warning letter to Merchants Market St. FDA expressed concern about insufficient follow-up.

“On December 12, 2018, we received your written response proposing corrective actions for the five (5) observations that were listed in Form FDA-483, Inspectional Observations, issued to your firm’s General Manager during the close-out meeting on November 15, 2018.,” the warning letter says. “Your response is inadequate in that you proposed to develop and implement a HACCP plan for your refrigerated products (including pasteurized canned crabmeat) but you did not propose an implementation date for this action and your mitigation action of continuing freezing the products upon receipt will not control the product related hazards during transit as explained above in this letter.

“You also indicated that a Standard Operating Procedure (SOP) for transit temperature monitoring has been implemented, but no records are included that could help in demonstrating its successful implementation, it continues. “Further, in your response, you proposed to maintain the temperature monitoring related records in your facility for a minimum of 90 days. Your proposed record retention timeframe is not in compliance with the requirements.”

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