FDA EIR - DPT Laboratories, Ltd - December 14, 2018

An FDA routine surveillance inspection was conducted at DPT Laboratories, Ltd in San Antonio, TX, from December 10-14, 2018. This inspection covered human and veterinary drug manufacturing operations, adhering to compliance programs for drug establishment and animal drug manufacturing inspections. The scope included the Quality, Facilities and Equipment, Materials, Production, Laboratory, and Packaging and Labeling Systems. The inspection resulted in three observations documented on Form FDA 483. Key issues identified included deficiencies in the Purified Water System, specifically regarding the review of logs, chart recorders, identification of critical gauges, documentation of alarms, and clarity on vendor responsibilities during sanitization. Additionally, the firm failed to accurately record specific components used in batch records during compounding. Lastly, the company did not adequately document the chain of custody and accountability for stability samples when transferred between chamber locations. Management at DPT Laboratories, Ltd acknowledged these observations and committed to providing a written response within fifteen business days, outlining their corrective actions. This inspection follows a previous FDA review in late 2017, where a single observation related to raw material release procedures was noted and subsequently corrected.