FDA 483 - Eagle Analytical Services, Inc. - June 17, 2013

An FDA inspection conducted from June 5 to June 17, 2013, identified significant deficiencies at Eagle Analytical Services, a contract testing laboratory in Houston, TX. The inspection, documented in an FDA Form 483, revealed multiple violations primarily concerning laboratory controls and quality system management, indicating a failure to adhere to current Good Manufacturing Practice (cGMP) standards and United States Pharmacopeia (USP) requirements. Key observations included a pervasive lack of validation for critical test methods, such as sterility and potency assays, and the absence of essential suitability testing for samples and growth promotion for media. The firm also failed to perform necessary calculations like Maximum Valid Dilution and endotoxin limits for drug products, and lacked adequate pH testing. Deviations from specifications, including the release of drug product samples despite failed positive controls in sterility tests, were noted without proper investigation or justification. Further issues highlighted incomplete and unreviewed laboratory records, including sterility and contamination tracking logs, and a critical absence of an effective Quality Control Unit with defined responsibilities. The firm also demonstrated inadequate control over electronic data systems, allowing unauthorized access and changes, and insufficient cGMP training for laboratory personnel. Eagle Analytical Services is required to promptly address these serious observations to ensure the quality, purity, and safety of drug products tested.