FDA 483 - Spartan Enterprises Inc. dba Watershed Wellness Center - July 25, 2022

Spartan Enterprises Inc. dba Watershed Wellness Center, a dietary supplement manufacturer in Lansing, MI, received a Form 483 with 8 observations, many of which are repeat findings from a previous inspection. The inspection revealed significant deficiencies across their quality control operations, including a lack of master manufacturing records, inadequate ingredient identity testing, missing component and finished product specifications, and incomplete batch production records. Additionally, the firm failed to qualify suppliers and maintain sanitary conditions in its manufacturing and storage areas.