FDA 483 - The Tender Corporation - November 25, 2019

An FDA inspection of Tender Corporation in Littleton, NH, revealed significant deficiencies in laboratory controls, record-keeping, and quality unit procedures for their OTC drug products, particularly After Bite. Repeated observations regarding inadequate specifications for ammonia content and widespread data integrity issues were noted, indicating a systemic failure to ensure product quality and compliance. The firm also failed to thoroughly investigate out-of-specification events and maintain complete batch production records.