Hard-E Foods Inc. does not have scheduled processes established by an acidified foods expert for its Pickled Eggs, Garlic Mustard Pickled Eggs, Beet Pickled Eggs, Sweet Pickled Eggs, and Hot Pickled Eggs.

The St. Louis-based manufacturer of acidified food products also failed to register with FDA as a commercial processor of acidified foods.

Those alleged violations and other “significant deviations” were enough to result in a Sept. 7 warning letter to Hard-E Foods Inc. from FDA’s Kansas City District.  The warning letter stems from an inspection of the St. Louis facility last May 4-7.

“The inspection revealed that you manufacture serious varieties of acidified food products at this facility,” the letter said.  It said a manufacturer of acidified foods must comply some specific federal regulations, including the registration requirement.

“Your firm has failed to file a scheduled process for each of the acidified foods you manufacture, ” FDA said.  “At this time, there are no acidified food scheduled processes filed with FDA for any of your firm’s pickled egg products.

“As a commercial processor engaged in the thermal processing of acidified food you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including conditions for heat processing and control of pH, salt, sugar, and preservative levels, and source and date of the establishment of the process for each acidified food in each container size…”

FDA said its investigation showed Hard-E Foods has been processing acidified foods at its current location for the past five years without registering with the agency as required by law.

FDA also told Hard-E Foods that its controls, including frequency of testing and recording of results, are insufficient.  “Specifically, your firm does not monitor or record the finished equilibrium pH of any of the acidified egg products you manufacture to ensure that finished product pH does not exceed 4.6.”

Hard-E Foods holds foods, which can support the rapid growth of undesirable microorganism, in a manner that can cause its products to become adulterated.  “Specifically, you allowed the ingredient of hard cooked eggs in a citric acid solution, which according to their label are to be kept refrigerated, to set for an undetermined amount of time at room temperature as observed by our investigator,” the warning letter said.

“In addition, after this incident was brought to the attention of your firm, the product was placed back under refrigeration and was not further evaluated.”

In addition to eggs, Hard-E Foods is a wholesale supplier to fresh cut fruits and vegetables.   The business was established in 1982.   FDA says the company must obtain and hold an emergency permit to make acidified food products.