FDA EIR - Laboratory Service Inc. - December 18, 2018

An FDA inspection of Laboratory Service Inc., a contract testing laboratory in Carteret, NJ, was conducted from December 10 to December 18, 2018. The inspection, performed under compliance program 7356.002 for Drug Manufacturing Inspection, focused on control testing laboratory operations. The inspection identified three significant deficiencies, documented on an FDA Form 483, primarily related to data integrity and laboratory control systems, referencing regulatory frameworks like 21 CFR 211.68(b) and 21 CFR 211.160(b).

Main violations included inadequate controls over computer systems, specifically the lack of user-specific access (usernames, passwords, roles, privileges) for chromatographic data processing software used with Gas Chromatography (GC) and Fourier-Transform Infrared Spectroscopy (FT-IR) instruments. This issue, coupled with the absence of audit trails, left electronic raw data vulnerable to unauthorized alteration or deletion. A critical finding was the failure to maintain robust backup files, as original electronic raw data for USP grade chemical samples from July 2016 to August 2018 were lost due to a hard drive crash and insufficient backup practices. The firm also lacked a written data backup and recovery procedure.

Additionally, laboratory controls were deficient in establishing scientifically sound test procedures. This involved a recurring failure to perform system suitability for GC analyses according to USP <621> guidelines, and a lack of routine calibration or adequate documented qualification for GC instruments.

Mr. Robert K. Conley, the company President, acknowledged these deficiencies and committed to providing a written response to the FDA 483 observations within 15 business days, outlining the firm's corrective actions.