FDA's Comment on Form 483 Detailing Basic Foods Inspection
On Tues. March 9, 2010, the FDA issued to Basic Food Flavors, Inc., of Las Vegas, Nev., a Form FDA 483 Inspectional Observations detailing the Agency’s inspectional observations at the facility where contamination with Salmonella Tennessee was found.
The form does not include the final Agency determination of the company’s compliance with the Federal Food, Drug, and Cosmetic Act, but rather, it details the observations made during the inspection by the inspection team.
In February, a customer of Basic Food Flavors alerted the FDA that it had detected Salmonella in the company’s hydrolyzed vegetable protein (HVP) product they had purchased from Basic Food Flavors. The company made the report through the FDA’s new Reportable Food Registry (RFR), prompting the FDA to begin its investigation which led to an inspection at Basic Food Flavors that began on Feb. 12. That inspection led to the FDA’s positive findings of Salmonella in the manufacturing facility.
The FDA then began discussions with Basic Food Flavors regarding the firm's intentions to conduct a voluntary recall of the HVP the company had made, in both powder and paste form, manufactured on or after Sept. 17. On Feb. 26, 2010, Basic Food Flavors began notifying its customers that it was recalling all of the HVP product in powder and paste form made since Sept. 17.
The initial RFR report, coupled with information learned by the Agency during its follow-up inspection, resulted in the FDA being able to quickly notify the public of the contamination affecting this widely used food ingredient.
To date, there have been no reports of illnesses.
Overview of the Form FDA 483 Issued to Basic Food Flavors
In addition to the firm's own Salmonella findings, the inspectional observations in the 483 detail significant issues in Basic Food Flavors’ manufacturing facility. FDA inspectors found problems in the company’s manufacturing processes, including a lack of microbial- contamination control. The 483 also identified problems with the cleaning and sanitizing procedures of equipment and work areas where food meant for human consumption is processed, as well as plumbing and drainage issues.
What Steps Will FDA Take in Response to these Findings?
The FDA is reviewing the evidence in association with the current inspection of Basic Food Flavors to determine the appropriate regulatory response. The agency has taken a proactive approach and has initiated a number of steps to protect the nation’s food supply in response to previous foodborne events, including.
- Increasing environmental monitoring and sampling during inspections of certain types of facilities;
- Utilizing a zoned approach to environmental monitoring within facilities by targeting areas known to be niches for microbial growth
- Instruction and training for state counterparts on how to replicate FDA’s techniques when they conduct their inspections;
- Significantly increasing the number of companies FDA targets for environmental sampling, including companies that manufacture products that are used as ingredients by other food processors.
FDA outreach to the food industry has resulted in the industry developing and implementing guidance on control measures for Salmonella within certain segments of the food industry. The guidance includes recommendations for environmental monitoring to verify these controls are effective. Industry trade associations are encouraging their members to implement this guidance and many companies are requiring their suppliers to follow it. This guidance applies to low moisture products such as HVP.
The FDA will continue to monitor this situation and update the public through public announcements or web postings should we learn of any additional information that would impact the public’s health.