FDA EIR - TPM Laboratories, Inc. - October 16, 2018

An abbreviated surveillance inspection of TPM Laboratories, Inc., a chemistry-only contract testing laboratory for drugs in Cherry Hill, NJ, was conducted by the FDA from October 15-16, 2018. This inspection, part of the New Jersey District FY2019 Drug Workplan, provided GMP coverage under CP7356.002 Drug Manufacturing Inspections. The inspection reviewed quality and laboratory control systems, covering areas such as method validation, residual solvents, training, instrument calibration, and data integrity for active pharmaceutical ingredients and finished drug products. Crucially, the inspection concluded without the issuance of an FDA-483 Inspectional Observations form, signifying that no significant objectionable conditions were formally identified. However, one specific item was discussed with management: the determination of the adequacy of laboratory instruments prior to use. This arose from an Out-of-Specification (OOS) investigation where a pH probe was suspected of being broken during analysis. As a required action, Ms. Rupa Iyer, President, committed to adding a column to the pH meter logbook to mandate visual inspection for cracks or leaks of the pH probe before each use, to be completed by October 2018. While some OOS investigations exceeded their targeted closure timelines, these had documented extensions due to external factors. Overall, the inspection found the firm generally operating in compliance with regulatory expectations.