483
Sota Precison Optics IncFDA 483 - Sota Precison Optics Inc - August 15, 2025
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An FDA inspection of Sota Precison Optics Inc., a manufacturer of dental x-ray systems in Orange, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, complaint handling, and finished device acceptance. These issues indicate a lack of robust controls over critical quality processes.
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