FDA EIR - TOLMAR Inc. - March 28, 2019

An FDA inspection of TOLMAR Inc.'s analytical laboratory in Fort Collins, CO, took place from March 25-28, 2019. This pre-announced inspection, conducted under compliance programs for Drug Manufacturing Inspections, focused on the firm's Quality and Laboratory Control System, specifically reviewing analytical method development and validation for new and approved drug products. The laboratory primarily supports internal Tolmar entities by developing and validating methods for raw materials, in-process substances, and finished products, then transferring them to commercial quality control laboratories. While no formal FDA 483 form with inspectional observations was issued, a key issue was verbally discussed during the close-out meeting. This concern related to the completion, control, and storage of hardcopy and electronic laboratory notebooks used in a specific QC laboratory. Investigators noted insufficient control over notebook templates and a lack of detailed procedures for scanning, identifying, and storing electronic versions of these records. TOLMAR Inc. management acknowledged these observations and committed to taking steps to correct the identified deficiencies.