A recent US Food and Drug Administration (FDA) warning letter to a contract drug-testing laboratory shows how incomplete records can expose deeper weaknesses in quality culture, investigation practices, and management oversight.
The FDA issued the letter to Auriga Research Pvt. Ltd. following a February inspection of its Bengaluru, India, facility. According to the agency, the laboratory did not maintain complete and original data for required testing and did not adequately establish or follow quality unit procedures. The facility tests drug products for the US market.
Incomplete records undermine data integrity
FDA investigators found blank spaces on raw data sheets for microbial tests, even though the corresponding summary reports contained final plate counts. Auriga told the agency that the affected samples were not associated with products intended for the US market. The FDA rejected that distinction because the facility uses the same quality system and procedures for US and non-US testing.
Auriga described the deficiencies as an institutional procedural and cultural gap rather than isolated employee misconduct. The FDA said the response did not adequately assess vulnerabilities in the laboratory’s paper-based documentation system or include a retrospective review for other incomplete or noncontemporaneous records.
For lab managers, the finding reinforces the need to assess whether staff can reconstruct each reported result from original records. Documentation controls must account for how analysts record observations at the bench, how supervisors review them, and how the quality unit identifies omissions before results move downstream. Digital systems can strengthen traceability, but technology cannot compensate for poorly designed workflows or weak review practices.
OOS investigations require scientific justification
The agency also cited an out-of-specification investigation in which the laboratory changed an autotitrator after an initial failure, a hypothesis test, and two repeat tests. The subsequent results passed, but the FDA said the laboratory did not scientifically support its proposed root cause or implement an associated corrective and preventive action.
The warning letter directs the company to complete an independent assessment of its laboratory practices, equipment, methods, documentation, and analyst competencies. It also requests a comprehensive CAPA plan addressing attributable, legible, complete, original, accurate, and contemporaneous records.
The FDA further emphasized that contract testing laboratories operate as extensions of the manufacturers that hire them. Laboratory leaders therefore need vendor qualification and oversight processes that extend beyond reviewing certificates, turnaround times, and service agreements. Quality agreements should establish how contractors communicate OOS results, data-integrity concerns, deviations, and other significant problems.
The case gives lab managers a practical inspection-readiness test: determine whether records tell the complete story of each analysis, whether investigations follow the evidence rather than the desired result, and whether the quality unit has the authority and resources to challenge gaps before they become systemic.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
