FDA 483 - The Tender Corporation - September 23, 2021

Tender Corporation received a Form 483 detailing significant deficiencies across its quality control, manufacturing, and complaint handling processes. Issues included inadequate laboratory record review, failure to follow stability testing and complaint procedures, and insufficient qualified personnel. The report also cited failures in OOS investigations, employee training, annual product reviews, and equipment cleaning and maintenance, indicating a broad lack of adherence to cGMP regulations.