FDAWarningcolor_406x250A food warehouse and repacking facility, a bakery, a dietary supplement repacking facility and an airport are all on notice from the Food and Drug Administration for violations of the federal Food, Drug & Cosmetic Act.

The FDA warned one company in March, another in April, the third in May, and the fourth in June. The warning letters that were sent to each of these companies were just recently posted for public view. The FDA allows companies 15 working days to respond to warning letters. If companies fail to promptly correct violations, legal action can result in seizure of products and injunctions stopping operations.

Sucesores De Esmoris & Co. Inc.
In a March 7 warning letter to company owner and president James Fox, the FDA described violations observed during an inspection from Oct. 31 through Nov. 18, 2016, at the company’s food warehouse and repacking establishment in Mayaguez, Puerto Rico. The company stores and repacks dried grains, wheat and corn flour, and cheese, according to the warning letter.

Facilities that store and repack human food products are required by federal law to comply with the Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (CGMP) regulations, which include taking effective measures to exclude pests from the processing areas, maintain sanitary facilities and equipment, and control thermometers to measure walk-in coolers temperature.

“Evidence of pests activity — what appears to be insect parts, dead cockroaches, and rodent pellets — was observed throughout your facility. The main front door that leads to the warehouse, where food is stored and dried grains repackaging operations are conducted, was opened at all times without screening protection,” according to the warning letter.

With the recognition of mice in the facility, Sucesores De Esmoris & Co. failed to provide a strategy, and continued to provide entry of pests through a door without screening protection, according to the warning letter.

“Accumulation of what seems to be filth and food debris — spilled food product — which had not been removed after each production’s day, (was) observed on the flooring underneath and around repackaging equipment,” according to the warning letter.

The FDA inspectors also noted that thermometers used to measure walk-in cooler temperatures were not accurate or adequately maintained.

Santo Agency Inc. bakery
In an April 3 warning letter to bakery manager Santos Parmar, the FDA reported serious violations of the current Good Manufacturing Practice (CGMP) regulations. According to the warning letter, food products were being prepared, packed or held under insanitary conditions, risking contamination with filth and rendering them injurious to health.

The Jan. 11-18 inspection in San Leandro, CA, showed that the company failed to provide, when necessary, adequate screening or other protection against pests.

“Failure to ensure all rubbish and any offal shall be so conveyed, stored and disposed of as to minimize the development of odor, minimize the potential for the waste becoming an attractant and a harborage or breeding place for pests and protect against contamination of food-contact surfaces, water supplies and ground surfaces,” according to the warning letter.

The FDA inspectors also noted, specifically, a spray bottle of plain water and a rag, as well as no washing and sanitizing of equipment and utensils before or after production. Hand washing facilities were also inadequate, according to the report, the company failed to provide effective hand cleaning and sanitizing preparations.

“Specifically, during the inspection your employees were observed washing their hands with a bar of soap sitting on the sink used for washing utensils. Bar soap has the potential to be a breeding ground for microbial activity. In addition, employees were observed drying their hands on a single cloth towel instead of using the towel dispenser which was empty and locked.”

Summit Nutritionals International
In a May 31 warning letter to Caesar DePaco, owner of Summit Nutritionals International Inc. in Branchburg, NJ, the FDA described the company’s “Hydrolyzed Salmon Collagen Powder 90% Protein” product as being misbranded because of violations of food labeling laws. In addition, inspections of the company’s parent firm in Lebanon, NJ, on Oct. 26 – Nov. 10, 2015, and again on Aug. 15 – Sep. 13 also noted similar misbranding violations for porcine, bovine and/or chicken collagen products.

According to the FDA, a protein powder product label was indicated as false and misleading. The product was observed as being repackaged and relabeled as Hydrolyzed Salmon Collagen Powder 90% Protein, but was actually Hydrolyzed Gelatin sourced from ‘(redacted)’.

“Additionally, the manufacturer’s label for the Hydrolyzed Gelatin product states that it is ‘MADE IN CHINA.’ Whereas the label for the Hydrolyzed Salmon Collagen Powder 90% Protein states that it is ‘Proudly Made in The USA’ and the Certificate of Analysis states ‘Country of Origin: United States of America’ which makes it appear that the country of origin labeling is also false and misleading,” according to the warning letter.

Food labeling laws also require the net quantity of contents be included, such as statements of weight, but the company’s product labels did not include all include the mandatory details.

According to the warning letter, “Records must be maintained that demonstrate that products are not manufactured from, processed with, or does not otherwise contain prohibited cattle materials [21 CFR 189.5(c)(1)]. During the inspection it was determined your firm receives collagen derived from (redacted) products or by-products; however, your firm was not able to provide any documentation to support the materials are free from bovine spongiform encephalopathy (BSE). Your firm also stated you do not have any established specifications for animal-derived ingredients to ensure they are BSE free.”

Eugene Airport
In a June 1 warning letter to Airport Director Timothy M. Doll, formal notification from the FDA indicated a change in classification at the Eugene, OR, airport from “approved” to “provisional.”

A Jan. 10 inspection of the facility, conducted under the Public Health Service Act (PHS Act), revealed a significant violation in the aircraft servicing area’s ability to prevent the introduction, transmission or spread of communicable diseases. The facility operators also failed to maintain it a clean and sanitary condition at all times.

“All persons who have handled soil cans or other containers which have come in contact with human wastes (are required to) wash their hands thoroughly with soap and warm water and to remove any garments which have become soiled with such wastes before engaging in any work connected with the loading, unloading, transporting or other handling of food, water or ice. However, our investigator observed the following conditions at the lavatory dump station: hand-sanitizer and no hand wash sink, soap, or sanitary towels.”

Airport officials sent a letter to FDA Jan. 24 that detailed a response to a previous inspection, in which the airport confirmed that hand-sanitizer is located at the lavatory dump station, and that hand washing stations are located at a distance between 260 and 300 feet away in the office space for all airline ground handling companies that operate from the Eugene Airport. FDA officials did not find the response adequate.

“Anti-septic hand-sanitizer products are an adjunct to hand-washing, and not a replacement for hand-washing. The reason for this is that ethanol hand-sanitizers are not effective against fecal-oral route viruses, such as norovirus and Hepatitis A virus, and difficult to remove from the hands in the presence of fecal material,” according to the FDA warning letter.

“A distance in excess of 260 feet is not considered to be readily available when evaluating the location of a hand wash sink relative to a lavatory dump station. An employee in search of a hand wash sink after removing human waste from an airplane has to open with his/her hands at least one door used by other personnel who may onboard water or food to airplanes, or flight attendants.

“The same inspectional observation was communicated to your firm at the conclusion of our February 2014 inspection. For these reasons, we find your written response inadequate to address the aforementioned violation.”

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