# FDA 483 - Best Dental Kit LLC - May 01, 2025

Source: https://www.globalkeysolutions.net/records/483/best-dental-kit-llc/733864b2-e8e9-4e20-93f7-5ed19dcb4579

> FDA 483 for Best Dental Kit LLC on May 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Best Dental Kit LLC
- Inspection Date: 2025-05-01
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: 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.

## Related Officers

- [Ruben C. Quintana](https://www.globalkeysolutions.net/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

Company: https://www.globalkeysolutions.net/companies/best-dental-kit-llc/67c7c165-d56f-403e-9a86-bdb248fb892b

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8