After an inspection of an RTE soy protein isolate manufacturing facility, FDA issued a 483, then a warning letter due to observations and continuing concerns about:
- The company’s incomplete hazard analysis in which it did not identify Salmonella as a hazard that could arise from the environment. Because there also was no further lethal treatment that would significantly minimize this pathogen, this needed to be included as a hazard.
- Sanitation was not identified as a reasonable preventive control for managing the hazard, and residual soy protein residue was observed on food contact surfaces after cleaning was completed. The company’s method of sanitization – using a UV ceiling light – was also considered inadequate as it may not be fully effective given the existence of unclean surfaces and the challenges of the light reaching to all surfaces due to shadowing, etc.
- It was not clear whether verification testing of the product and the environment for Salmonella had been completed as indicated in various verification programs.
- Additionally, GMP violations included the observation of live insects and improper maintenance of exterior grounds, with excess waste and vegetation observed outside the building where the soy protein isolate was packaged.
