FDA 483 - Vet Cellect Bio Products, LLC - July 09, 2021

Vet Collect Bio Products, LLC, an own label distributor of veterinary drug products in Manalapan, NJ, was cited for distributing an unapproved veterinary drug product, ExCellR8 Topical Cream, despite multiple notifications to cease marketing. The firm also failed to provide quality oversight for the contract manufacturing of this product, lacking analytical data and quality agreements with suppliers. These observations indicate significant deficiencies in regulatory compliance and quality control for their distributed products.