FDA EIR - DPT Laboratories, Ltd - May 05, 2023

This FDA Establishment Inspection Report details a five-day inspection of DPT Laboratories, Ltd in San Antonio, TX, conducted from May 1 to May 5, 2023. The facility manufactures a range of products, including prescription animal and human drug products, over-the-counter human drugs, dietary supplements, and medical devices, distributing them interstate.

The inspection identified a significant manufacturing control issue related to product contamination prevention. Specifically, during the filling and packaging operation of a product, an employee performing pump prime maintenance was observed opening and closing the hopper lid and scraping product contact surfaces inside the hopper using the same gloves that had touched non-clean surfaces. The utensil used was also left within the product hopper.

These observations indicate a lapse in adherence to proper hygiene and contamination control techniques, which are critical for maintaining product integrity and preventing adulteration, falling under the regulatory framework of Good Manufacturing Practices (GMP) for drug manufacturing.

DPT Laboratories, Ltd is therefore required to implement corrective actions to address these procedural deficiencies. This includes ensuring that personnel follow strict contamination control protocols, utilize appropriate cleanroom practices, and manage tools and equipment correctly to safeguard product quality and ensure patient safety in accordance with regulatory expectations.