FDA 483 - TBN Labs, LLC. - March 03, 2021

Total Body Nutrition LLC, a dietary supplement manufacturer in Edgewood, NY, was cited for numerous deficiencies during an FDA inspection. The firm failed to establish and verify product specifications, conduct identity testing for ingredients, maintain complete batch production records, and follow cleaning procedures. Additionally, the company lacked essential written procedures for personnel hygiene, pest control, and did not retain reserve samples of distributed products.