A seafood facility, tortilla company, juice manufacturer and acidified food processor are all on notice from the Food and Drug Administration for violations of the federal Food, Drug and Cosmetic Act.

The FDA warned one company in May, and the other three in June of 2017. The warning letters were just recently posted for public view. The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in seizure of products and injunctions stopping operations.

Pulido Associates, Inc.
In a May 8 warning letter to company owner and president Roberts Pulido Sr., the FDA described violations observed during an inspection from Dec. 14 through Dec. 16, 2016, at the company’s facility where they manufacture acidified food products. The Benbrook, TX, commercial processing facility engages in the thermal processing of acidified foods, according to the warning letter. Acidified food processors are required by federal law to comply with Current Good Manufacturing Practices in Manufacturing, Packing, or Holding Human Food, which includes taking effective measures to keep conditions sanitary.

The firm had no measurement instruments to control or prevent the growth of microorganisms, and had no records of pH meter calibration to conduct finished equilibrium pH testing, according to the warning letter. The firm also failed to apply manufacturing codes for their “Tomatillo Salsa” and “Salsa Fesca” 16-ounce bottles.

The inspector also noted that, “Specifically, you have a ripped and worn fabric covering over the chute of your corn dispenser. This worn fabric covering can introduce foreign materials and other contaminants into your acidified food product. Furthermore, you have a rubber mat on the outlet of the corn grinder, a food contact surface, with observed filth build up that may be introduced into finished product.”

Pressure Safe
In a June 7 warning letter to company president Michael Morasch, the FDA reported serious violations of the current juice Hazard Analysis and Critical Control Point (HACCP) regulation. According to the warning letter, the juices were prepared, packaged or held under unsanitary conditions.

The Feb. 23 inspection in Portland, OR, showed that the company failed to provide HACCP plan control measures that will consistently produce, at a minimum, a 5-log reduction of the pertinent microorganism, for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions, according to the warning letter. A 5-log reduction equates to a 100,000-fold reduction.

Along with multiple other violations in measuring and monitoring processes, the FDA noted that the company also failed to record a hand written “HPP Monitoring HACCP Log.”

“The studies all conclude that the HPP processing conditions from the study result in at least a 5-log reduction and can be applied to juice with a pH equal to or less than the juice(s) studied. However, no scientific support was provided to substantiate such conclusion. As stated above, FDA is not aware of any broad HPP validation study that covers juice products with varying compositions, characteristics, pertinent microorganisms, etc.,” according to the warning letter.

“In addition, details of many potentially important product and processing conditions during validation are unknown, such as product water activity, percent solids, Brix, product temperature, and pressurization fluid temperature. For each validation study, it appears that only one HPP process run with multiple samples was evaluated and there was no true replication of the HPP process to understand process variability.”

Lopez Tortilla Foods Inc.
In a June 14 warning letter to owner Armando J. Lopez, the FDA reported serious health violations of Good Manufacturing Practices (GMPs) for human and animal food products. According to the warning letter, human food products were being prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or rendered injurious to health.

The Jan. 24-27 inspection in Dallas, TX, showed that the company failed to take effective measures to exclude pests from the processing areas and to protect against contamination of food on the premises by pests.

“Rodent excreta pellets were observed on top of final product packaging of three finished products in your distribution warehouse. Also, a cat was observed entering a storage area used to house ingredients,” according to the warning letter.

“Four of the roll up bay doors in your receiving and distribution area were found to be in disrepair with holes ranging from approximately 1 to 8 inches. A similar observation was also brought to your firm’s attention at the close out of inspections in 2014, 2009 and 2011.”

Several other concerns come from the following significant violations:

  • The company failed to store finished food under conditions that will protect the food against physical, chemical, and microbial contamination, as well as, against deterioration of the food and the container.
  • The company failed to clean and sanitize utensils and equipment in a manner that protects against contamination of food, food contact surfaces, or food-packaging materials.
  • The company failed to adequately drain areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests.
  • The company failed to require personnel to wash their hands thoroughly in an adequate hand-washing facility before starting work, after each absence from the work station, and at any other time when hands may have become soiled or contaminated.

“Bare hands (were used) to prepare packaging materials such as cardboard boxes and tape guns. These same employees were then observed using bare hands to handle ready to eat, finished product, tortillas and tortilla corn chips without first washing their hands,” the warning letter stated.

The report noted that the rounder divider for tortilla dough was soiled with dark rings throughout the surface of the conveyor. Also, standing water was observed under the corn cooking system, proving a harborage for pathogenic organisms.

Goff Seafood
In a June 19 warning letter to Herbert Goff, owner of Goff Seafood in Dry Prong, LA, the FDA described the company’s serious violations of the Current Good Manufacturing Practices (CGMPs).

Insanitary conditions were observed in the facility at the time of inspection, leaving the products contaminated or at risk for contamination from filth, rendering them injurious to human health.

The FDA noted that during the inspection, rain water was observed leaking from the roof of the pole barn style storage facility, and being blown into the storage area. This directly accumulated on 10 freezers which contained product, that were being stored outside, under the pole barn.

“The exterior and interior of the freezers containing bulk and finished product had exposed rust and chipping paint. No fewer than eight of the freezers had exposed insulation. No fewer than five of the freezers lids did not fit securely. A beetle type insect was observed in the exposed insulation of one freezer located under the pole barn style storage facility,” according to the warning letter.

Also, raw shrimp freezers did not have thermometers to indicate temperature measurement, or temperature recording, according to FDA.

Sanitary toilet facilities were not adequate and readily accessible, as the inspector noted an outhouse with apparent fecal matter in the toilet bowl. Additionally, convenient hand-washing facilities are an FDA requirement that were not present.

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