483
Park Dental Research CorpFDA 483 - Park Dental Research Corp - February 14, 2025
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An FDA inspection of Park Dental Research Corp, a class II dental implant manufacturer in Ardmore, OK, revealed significant deficiencies. The firm failed to adequately document process validation activities, establish procedures for in-process product control including sterilization audits and cleaning, and maintain proper equipment maintenance records. These issues indicate a lack of robust quality system controls.
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- Dallas District Office
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