FDA EIR - North American Science Associates, LLC - December 09, 2011

An FDA inspection of North American Science Associates Inc. (NAMSA) in Northwood, OH, occurred from November 28 to December 9, 2011. This comprehensive pre-approval inspection, conducted under CPGM 7346.832 and 7356.002, assessed the contract laboratory's adherence to Good Manufacturing Practices (21 CFR Part 211) for drug and medical device testing.

The inspection identified three primary violations detailed in an FDA Form 483. First, the quality control unit failed to establish and approve complete specifications and test procedures. Issues included not always obtaining client specifications, lacking defined procedures for sterility operator gown monitoring, inadequate system suitability testing for analytical methods, and unauthorized worksheet changes. Second, the accuracy and reliability of test methods were not consistently established, with unvalidated non-compendial methods and a lack of subcontractor method validation/verification. Third, investigations into out-of-specification results, such as clean room air pressure issues, lacked documented root causes and effective corrective actions.

Management expressed cooperation and outlined planned responses. These include implementing a corrective action to require client specifications, updating pyrogen study data sheets, clarifying SOPs for document changes, evaluating the validation status of test methods, and improving investigation documentation. Additionally, NAMSA agreed to review water system maintenance and media sterilization cycle times to enhance overall quality controls.