FDA 483 - Fidelitone Order Fulfillment LLC - October 26, 2023

On October 24-26, 2023, the FDA inspected Fidelitone Order Fulfillment LLC, a repacker/relabeler located at 125 E Forrest Ave, Lebanon, TN. The inspection, led by Investigator Clinton J. Lott, identified a critical deficiency: the absence of a quality control unit.

Specifically, the firm lacks established and followed procedures for several key quality functions: 1. **Change Control:** No SOP exists, and a change to the warehouse management system (used for tracking repackaged products like acne gel and shampoo/conditioner) was initiated in June 2023 without a change control process. 2. **Label Creation/Issuance:** No SOP for label control. The client care specialist prints pallet labels (including product name, lot, and expiration date) for products like acne gel and shampoo/conditioner without formal procedures for creation, issuance, or control. 3. **Corrective and Preventive Actions (CAPA):** No SOP for initiating or tracking CAPAs. The firm purchased new inkjet printing machines in 2021 due to multiple failures of old machines (used for printing lot numbers and expiration dates on acne gel packaging), but no investigations or CAPAs were initiated for these failures. 4. **Qualification/Validation:** No SOP for qualification/validation. Processes and equipment, including the new inkjet printing machines purchased in 2021 for acne gel packaging