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FDA’s data for 2020 shows top five violation categories at food facilities

The FDA’s Inspection Observation Data for the Fiscal Year (FY) 2020, depicting how frequently particular violations were found during food facility inspections between October 2019 and September 2020, are out. Hampton, VA-based Registrar Corp. did this breakdown of the data from the Food and Drug Administration and provided analysis of the top five violation categories […]

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The FDA’s Inspection Observation Data for the Fiscal Year (FY) 2020, depicting how frequently particular violations were found during food facility inspections between October 2019 and September 2020, are out.

Hampton, VA-based Registrar Corp. did this breakdown of the data from the Food and Drug Administration and provided analysis of the top five violation categories cited by FDA inspectors during FY 2020:

1. Foreign supplier compliance programs
Under the Food Safety Modernization Act (FSMA), FDA requires most food importers to develop and maintain Foreign Supplier Verification Programs (FSVPs) for their suppliers. The requirement is designed to help ensure that suppliers are FDA compliant and are producing food in a safe manner. 

During FSVP inspections, the FDA expects importers to present complete FSVPs that adequately assure suppliers’ food safety. In FY 2020, the FDA cited 514 facilities for failing to develop an FSVP. While most food facility inspections were halted for the majority of 2020 because of the COVID-19 pandemic, the FDA continued to conduct FSVP inspections remotely. FSVP citations increased by 51 percent compared to 2019. This is the third year in a row that failure to develop an FSVP was the top-cited inspection violation. 

2. Hazard analysis
In 2020, the FDA cited 104 cases where facilities failed to provide adequate hazard analysis. The agency requires most food facilities to identify potential biological, chemical, or physical hazards that may occur at the facility as well as establish preventive controls for those hazards. This is another way the FDA ensures that facilities are maintaining food safety protocols.  

These hazards can vary. For example, a facility can identify that it is possible for pathogens to survive processing intended to eliminate them. Alternatively, the facility can identify areas where inadequate cleaning of equipment can lead to allergen cross-contact. 

3. Pest Control
During facility inspections, the FDA inspectors search for signs of potential pest infestations. The FDA cited 98 facilities for failure to prevent pests within their food facility or for misusing pesticides in a way that could cause potential food contamination. 

4. Manufacturing controls
Manufacturing, processing, packing, and holding controls account for 95 of 2020’s food facility citations. This citation indicates that a facility did not conduct operations under conditions that would minimize the chances for potential microorganism growth, allergen cross-contamination, or contamination and deterioration of food. FDA requires facilities to provide controlled environments when handling food products to avoid potential health risks to consumers. 

5. Personnel
The fifth most cited violation during food inspections in FY 2020 were personnel issues. These can include failing to address hygiene issues or other good manufacturing practices in relation to employees’ handling of food products. The FDA issued 87 citations for this violation. 

Sanitation citations
While no sanitation citations made it into the top five on their own, sanitation citations make up a significant portion of the FY 2020 violations when combined with other violations. For example: 

  • FDA cited seafood processing facilities 81 times for failure to properly monitor their sanitation practices. These could include, but are not limited to, not properly monitoring “safety of the water that comes into contact with food, condition and cleanliness of food contact surfaces,” or “maintenance of handwashing, hand sanitizing, and toilet facilities.” 
  •  FDA cited 80 facilities for plant maintenance and sanitation issues. These are the result of failing to maintain a clean and sanitary food facility, which can also pose environmental threats to food products. FDA cited facilities for failing to sanitize their equipment 58 times. 
  •  FDA cited facilities 45 times regarding sanitation of food contact surfaces. This usually means that utensils and surfaces used in food preparation were not properly cleaned to prevent product contamination. 

Preparing for FY 2021
While FSVP violations saw a significant increase, the other top citations were issued fewer times in FY 2020 than in FY 2019. This is likely because of the temporary postponement of most food facility inspections in 2020 as a result of COVID 19.

For 2020, FDA food facility registrations totaled 241,567 worldwide. Registrations for 2021 are off about 25 percent at 182,147.

 Registrar Corp.’s food safety experts help companies pass facility inspections and comply with other FDA regulations.

(To sign up for a free subscription to Food Safety News, click here.)

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Disney California Adventure theme park plans to host a food festival tentatively by March

© P_Wei/Getty Images Disney California Adventure theme park plans to host a food festival tentatively by March Disney announced it will tentatively host a food festival at California Adventure Park in mid-March. The “all-new, limited-time ticketed experience” will also feature “unique, carefully crafted entertainment experiences.” Disney recalled about 1,000 employees who were laid off or […]

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a large ship in the water: Disney California Adventure theme park plans to host a food festival tentatively by March


© P_Wei/Getty Images
Disney California Adventure theme park plans to host a food festival tentatively by March

  • Disney announced it will tentatively host a food festival at California Adventure Park in mid-March.
  • The “all-new, limited-time ticketed experience” will also feature “unique, carefully crafted entertainment experiences.”
  • Disney recalled about 1,000 employees who were laid off or furloughed due to the pandemic to work the event.

Disney announced on Monday plans to host a food festival tentatively scheduled for mid-March after the state lifted its stay-at-home order last month.

In a letter commemorating the 20th anniversary of the California Adventure Park, Disneyland Resort President Ken Potrock said the “all-new, limited-time ticketed experience” will feature “world-famous food and beverage offerings from around the resort, the latest merchandise and unique, carefully crafted entertainment experiences.”

The event will have “limited capacity and enhanced health and safety measures in place,” Potrock added. The food festival prompted the company to recall about 1,000 employees who were laid off or furloughed because of the ongoing COVID-19 pandemic.

“This past year has presented extraordinary challenges, but that has not curtailed in any way our ability to move forward with a spirit of optimism,” Potrock said in the memo to employees.

California Gov. Gavin Newsom issued a regional stay-at-home order in early December of last year as COVID-19 infections surged in the state. Newsom lifted the order on January 25 “as projected ICU availability over 4 weeks in all regions rose to over 15%,” according to a press release.

Disneyland and its rides will still remain closed amid the ongoing pandemic. California reported nearly 10,500 cases and more than 200 deaths on Monday. More than three million cases have been reported in California, and the death toll in the state surpassed 44,000.

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Oregon’s food safety program fees could increase if bill earns legislative approval

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Legislators in Oregon are considering whether to allow the state’s Department of Agriculture to increase fees for food safety program fees.

The bill in question, Senate Bill 33, has the backing of Gov. Kate Brown. In addition to the fee increases the bill would declare an emergency in relation to the food safety programs, according to the summary of the bill.

“This 2021 Act being necessary for the immediate preservation of the public peace, health and safety, an emergency is declared to exist, and this 2021 Act takes effect on its passage,” states Section 2 of the bill.

The bill involves 15 percent increases in the next two state fiscal years for food safety program fees. It specifically states that it does not alter or effect the agriculture department’s authority to adopt rules imposing additional license fees.

If approved by the Oregon lawmakers, the legislation would allow the agriculture department to increase the program fees by 15 percent in each of the two coming fiscal years, which begin on July 1 in 2022 and 2023. 

The emergency declaration in the proposed legislation would become effective immediately upon the bill’s approval.

(To sign up for a free subscription to Food Safety News, click here.

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Public will be kept out of public health department’s ketamine review process

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DENVER (KDVR) — The months-delayed state health department review of Colorado’s ketamine waiver program will remain confidential, according to Michelle Reese, a Colorado Department of Public Health and Environment (CDPHE) employee familiar with the ketamine review.

“We intend to keep not only the work of the investigatory panel confidential but also the members at least until a final report is produced,” said Reese, who provided an update during Monday’s Emergency Medical Practice Advisory Council meeting. 

The group, also called EMPAC, is responsible for approving  ketamine waivers for medical directors.  The waivers allow paramedics, practicing under the medical director’s supervision, to administer the drug to patients prior to arriving at a hospital.

Reese said details about the review mostly would be kept confidential.

FOX31 reported in December that CDPHE had quietly paused the review process before ever naming any panelists despite an August 2020 announcement by CDPHE’s executive director, Jill Hunsaker Ryan, that the review would immediately begin.

“We wanted to connect with the AG’s office and make sure that he work that we were going to be doing would not interfere with their investigations,” said Reese of the Colorado Attorney General’s investigation into Elijah McClain’s death, which was announced prior to the ketamine review announcement, in June 2020.

McClain died in August 2019 days after an altercation in which police used the carotid hold on him and after paramedics subdued him with ketamine.

Reese said the ketamine review process had once again resumed, but the public would not be made aware of the progress until the review was complete.

“We want (the panel of experts) to be able to do their work unfettered and without fear of recrimination – for any individual member – as far as expressing their opinion and feeling comfortable that they can do so without being harassed or contacted. So, we really are going to try to keep the workings and everything of this panel confidential until everything is concluded.”

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