FDA 483 - The Tender Corporation - November 25, 2019

During an inspection conducted from November 12-25, 2019, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483 to Tender Corporation, a human drug manufacturer. The observations highlighted significant deficiencies in the company’s adherence to Current Good Manufacturing Practices (CGMPs).

Key issues included a repeated failure (since 2016) to establish scientifically sound specifications for ammonia content in their After Bite OTC liquid drug product. This omission was linked to customer complaints of strong odors, skin irritation, and burns.

Furthermore, inspectors found critical data integrity concerns, such as incomplete laboratory records where unofficial test results were not included in official documentation. Control over analytical instruments was inadequate, with shared administrator access allowing data modification. Batch production records were also found deficient, with operators initially recording critical manufacturing data on uncontrolled paper before transcribing it.

The inspection also revealed a failure to thoroughly investigate multiple out-of-specification results for the sodium bicarbonate assay, leading to recurring analytical discrepancies. A significant software update for their liquid chromatography system lacked proper change control and was implicated in these analytical failures.

Tender Corporation is required to provide a robust response detailing their comprehensive corrective and preventive actions to address these serious violations and ensure the quality, safety, and integrity of their drug products.