FDA says, “No Me Gusto”

May 7-8, 2019 and June 7, 2019 FDA inspected Tugusto Foods, down in Puerto Rico. We like this Warning Letter because we can see some label violations, but we would be remiss to not at least give the highlights of the serious cGMP and related food safety violations observed. If anyone is looking for either a clear example of how not to operate a food facility, or even perhaps a comprehensive guide to attracting and collecting pests – this read is hard to beat.

Some of the highlights:

  • Did not implement a food safety plan.
  • Did not conduct a hazard analysis of potential pathogens that could contaminate food.
  • Did not take effective measures against pests.
  • Had rodent excreta at the entrance of the production and packaging area.
  • Had dead cockroaches, dirt, and pieces of dead insects in the warehouse and next to a sink.
  • Had a fly on a utensil used for repacking food.
  • Amassed a collection of waste, wooden pallets, old paperwork (maybe overdue notices for unpaid pest control contracts?!), materials, and equipment that could serve as a perfect breeding area for pests.
  • Had employees not washing hands, doing proper glove changes, keeping personal items away from in-process products, wearing beard nets, removing earrings, and so much more.
  • Had one employee packaging food that went to the restroom with his gloves on, returned to his workstation, and continued working wearing the same gloves!
  • Enough said.

Of additional interest, the FDA cited them for a handful of label violations:

  1. Did not include a Nutrition Facts panel.
  2. Did not include a full list of ingredients by common or usual names.
  3. Did not make a nutrient content claim properly.
  4. Declared ingredients that were not actually in the product.

Of additional interest, the FDA wrote in a reminder of the new label regulations.

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.