From July 9th– 17th the FDA inspected a fresh cut produce manufacturing facility located in Texas. The inspection resulted in the FDA issuing of a Warning Letter to the company. There were numerous severe violations. Although there were not labeling based issues, the violations in regards to cGMPs and PCs were numerous.
So now let’s dive into the violations listed in the Warning Letter released.
- It was found that there was a lack of implementing preventative controls and conducting a hazard analysis within the facility. During inspection the FDA concluded that the company had not provided adequate preventative controls as seven (7) environmental swabs collected by the FDA during inspection were positive for L. monocytogenes, an environmental pathogen. The locations where the swabs were sampled included a crack in the floor, the side of a waste basket, as well as a squeegee in the Fruit Room. Furthermore, a retail product sample collected by the FDA at Wal-Mart in May 2019 also tested positive for L. monocytogenes. Which further solidified that there were inadequate sanitation procedures at the facility.
- The plant also did not prevent cross-contamination during washing
- There were as well observations of employees not following the established in the company’s food safety plan.
- The company also did not validate if the preventative controls are adequate to actually control the hazard. Specifically, cross-contamination was not validated. There was a study presented by the company to the FDA which specifically spoke about food contact surfaces and Salmonella choleraesuis and Listeria monocytogenes, however the FDA found that the study was not adequate to validate the efficacy against cross-contamination during the washing of the produce.
To read the letter in full, click HERE.
If anything in the letter sounds familiar from your facility, or you would just like to be better prepared for your own FDA inspection when the time comes, let us know. In addition to label compliance reviews, we do facility audits and consulting on following cGMPs. Contact us today to discuss your needs and get a free quote.