FDA EIR - DPT Laboratories, Ltd - May 29, 2024

An unannounced FDA inspection of DPT Laboratories, Ltd., a human drug manufacturer in San Antonio, TX, was conducted from April 15 to May 29, 2024. This surveillance inspection, following FDA's Drug Manufacturing Inspections Compliance Programs (7356.002 Drug Manufacturing Inspections), covered key systems including Quality, Facilities and Equipment, Materials, Production, Packaging and Labeling, and Laboratory. The company produces prescription animal drug products, as well as prescription and over-the-counter (OTC) human drug products.

Crucially, at the conclusion of the inspection, no FDA 483, Inspectional Observations, were issued to the firm, indicating no significant violations or regulatory deficiencies were identified. The report specifically noted 'no deficiencies were noted' across various reviewed areas, such as training procedures, quality unit responsibilities, annual product reviews, investigation processes, cleaning validation, facility cleanliness, equipment calibration, pest control, and water system monitoring. The previous inspection in May 2023 was also classified as 'No Action Indicated.' While management received a verbal reminder to keep product listings updated, this was a discussion point, not a formal observation or required corrective action. Overall, the inspection found the facility to be in good standing with regulatory requirements.