FDA EIR - Alturas Analytics, Inc - May 05, 2020

An FDA inspection of Alturas Analytics, Inc., a Contract Research Organization (CRO), was conducted remotely from April 14 to May 5, 2020. This surveillance inspection reviewed the company's operations under Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and electronic recordkeeping guidelines (21 CFR Part 11). The inspection resulted in a Form FDA 483, Inspectional Observations, being issued to President Robin A. Woods, detailing several significant issues.

The main violations identified included the Quality Assurance Unit's (QAU) failure to ensure that standard operating procedure (SOP) deviations were properly authorized and documented, as well as its failure to adequately review study reports. Further observations noted deficiencies in the retention of raw data and in the maintenance of comprehensive equipment records. The inspection team also discussed the QAU's in-process audits of GLP studies with management.

While specific corrective actions were not finalized during the closing discussion, Alturas Analytics, Inc. committed to providing a written response to the FDA 483 within 15 business days. Management was formally reminded of their obligation to operate in compliance with the Food, Drug, and Cosmetic Act, and the potential for agency remedial actions was discussed. This inspection followed a previous review in 2018, where a prior observation had been confirmed as corrected.