The facility was inspected from August 16, 2022, to October 14, 2022, and was issued a Form FDA 483 on October 14, 2022 (FDA, 2024a). The facility responded to the Form FDA 483 on November 4, 2022 (FDA, 2024a). The Warning Letter states that the facility is still deficient in their corrective actions (FDA, 2024a)