FDA 483 - Moon Valley Natural Products LLC - February 28, 2017
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An FDA inspection of Wood Valley Natural Products LLC in Deming, WA, revealed extensive deficiencies across its manufacturing operations for over-the-counter (OTC) drug products. The firm lacked a functional quality control unit, failed to establish proper laboratory controls, specifications, and testing programs for raw materials and finished products. Significant issues were also noted in equipment maintenance, facility sanitation, calibration procedures, record-keeping, stability testing, and deviation documentation, indicating a severe lack of adherence to Good Manufacturing Practices.
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