483
Best Dental Kit LLCFDA 483 - Best Dental Kit LLC - May 01, 2025
Record Details
Best Dental Kit LLC in Shavertown, PA, a repacker of dental kits, was cited for significant deficiencies in its quality control unit, complaint handling, storage conditions, and employee training. The inspection revealed a complete lack of written procedures and records for critical quality operations, inadequate personnel qualifications, and a failure to ensure proper environmental controls for drug products. These issues indicate a systemic breakdown in the firm's adherence to current Good Manufacturing Practices.
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ID · 733864b2-e8e9-4e20-93f7-5ed19dcb4579