A South Carolina ice pop manufacturer and an Oregon low-acid canned food producer are both on notice from the Food and Drug Administration for violations of federal food safety rules.

The FDA sent the warning letters to the companies in August 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.

King of Pops North Charleston, SC
In an Aug. 3 warning letter to CEO Steven Carse and COO Nicholas Carse, the FDA described violations observed during an inspection June 12-14, at the King of Pops manufacturing facility in North Charleston, SC. The company manufactures ice pops at the plant, according to the warning letter.

All people working in the manufacturing, packing, or holding of human foods are required by federal law to comply with the current Good Manufacturing Practice (cGMP) Regulations.

The FDA inspector noted several significant violations. First was a failure to take measures to exclude pests from the processing areas and to protect against the contamination of food on the premises by pests.

“Specifically, our investigators discovered evidence of insect and rodent activity near foods stored in your food processing facility,” according to the warning letter.

The following were observed in the facility’s production areas during the inspection:

  • About 55 rodent excreta pellets (REPs) in the rear right corner of the production facility underneath a food storage rack;
  • About 45 REPs located inside of a raw ingredient storage box and other ingredients on the middle rack of a storage rack;
  • About 16 REPs in the rear middle wall of the production facility underneath a food storage rack;
  • About 20 REPs on the interior and exterior of the water heater basin located in the front right corner of the production facility;
  • Three REPs on the front middle wall located underneath the cook table; and
  • Seven live fly-like insects throughout the production area that were observed landing on food contact surfaces, production surfaces, and where food was being stored.

After the FDA collected the REP samples during the inspection, laboratory analysis confirmed the material consisted of rodent excreta pellets, confirming the presence of rodents in the facility.

The FDA also noted the firm’s failure to properly clean and sanitize utensils and equipment in a manner that protects against contamination of food and food-contact surfaces. Additionally, the FDA inspector noted that the plant is not constructed in such a manner that allows floors, walls and ceilings to be adequately cleaned and kept clean and kept in good repair.

“Such areas are not able to be easily cleaned and provide harborage sites where pathogenic microorganisms can grow and survive. Also, there were areas with visible standing water and what appeared to be accumulated debris around production tables and food storage racks,” according to the warning letter.

Additionally, the firm failed to maintain gloves, used in food handling of finished food products, in an intact, clean, and in sanitary condition, as “investigators observed production employees touching non-food contact surfaces such as their face, a ball cap, sink handles, compost buckets, refrigerator handles, and trash cans and then return to handling food contact equipment without changing their gloves or washing their hands.”

The firm also failed to provide adequate floor drainage, maintain all plant equipment and utensils, provide safety-type light bulbs and lighting fixtures suspended over exposed food. The report noted that the firm “failed to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures” and “failed to provide, where necessary, adequate screening or other protection against pests.”

On June 28 the firm’s production manager responded to the FDA with the planned efforts and actions they would take to fix violations. However, the majority of these responses were declared as “ineffective,” “unclear,” had no time frame for planned actions, or “did not demonstrate a correction of the observed violation,” according to the warning letter.

“We do not consider this corrective action to be adequate as no evidence was provided that allows us to more thoroughly evaluate the effectiveness of the described corrective action.”

Oregon Wild Berries Westport, OR
In an Aug. 9 letter to president Stanley J. Egaas, the FDA cited serious violations of the low-acid canned food regulations (LACF) at the Oregon Wild Berries low-acid canned food processing facility. The FDA discovered and documented problems at the Westport, OR, facility May 9 through May 23.

According to the warning letter, the firm’s low-acid canned food may be adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth or rendered injurious to health.

All manufacturers of low-acid canned food are required to comply with the Federal Food, Drug, and Cosmetic Act.

“A temporary emergency permit may be required for low-acid canned foods whenever a processor has failed to fulfill the requirements of 21 CFR 108.35, including registration and filing of process information, and the mandatory requirements of 21 CFR 113,” according to the warning letter.

Although the firm responded to the FDA on June 1 with a letter including a narrative description of the corrective actions taken, the FDA notes the following, unresolved, significant violations:

  • The firm failed to provide evidence in the form of heat distribution data to demonstrate adequate venting of facility equipment;
  • The firm failed to measure and record critical factors specified in the scheduled process at intervals of sufficient frequency to ensure that the factors were within the limits specified in the scheduled process;
  • The firm failed to identify deviations from the filed scheduled process, such as adequate processing for self-venting glass jars of clam chowder concentrate; and
  • The firm failed to record the results of visual examination of the container closures at intervals of sufficient frequency to ensure proper closure, such as how or if products were “sealed.”

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