FDA 483 - Spectral Data Services, Inc. - July 28, 2025
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Spectral Data Services, Inc. in Champaign, IL, a contract testing laboratory, received a Form 483 for significant deficiencies in its quality systems. The firm failed to adequately follow quality control procedures, maintain proper computer system controls for data integrity, and conduct thorough investigations into discrepancies. Additionally, employees lacked adequate training for their assigned functions, indicating a systemic lack of adherence to good manufacturing and laboratory practices.
ID · 17e5c8dc-0f04-4cc0-a5bc-101d0aede860