FDA EIR - Surmasis Pharmaceutical, LLC - March 01, 2018

An FDA inspection of Surmasis Pharmaceutical in Des Moines, IA, was conducted from February 12 to March 1, 2018. This comprehensive initial inspection, targeting the firm's readiness for an Abbreviated New Drug Application (ANDA) under FDA's Pre-Approval and Drug Manufacturing Inspections programs, revealed five significant deficiencies. The identified issues included incomplete laboratory records, specifically the omission of failed test results, a lack of audit trails for unreported data, and missing electronic results for incoming raw materials. Investigators also noted inadequate controls over computer systems and the absence of validation for internally developed software functions. Procedural weaknesses were cited due to insufficient detailed instructions for manufacturing, cleaning, and testing operations. Furthermore, laboratory controls were found deficient, exemplified by a policy allowing results outside of established standards to be invalidated without a thorough root cause investigation, unvalidated test methods, and no defined alert or rejection limits for in-process sampling. Surmasis management received a warning about their responsibilities under the Federal Food, Drug, and Cosmetic Act and the potential consequences of non-compliance, indicating an urgent need to address all observed deviations to achieve regulatory compliance.