# FDA 483 - Dental Alliance Holdings LLC - October 24, 2024

Source: https://www.keypedia.com/records/483/dental-alliance-holdings-llc/25734b20-f436-4a7e-97b1-8bd2d482901d

> FDA 483 for Dental Alliance Holdings LLC on October 24, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dental Alliance Holdings LLC
- Inspection Date: 2024-10-24
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection of Dental Alliance Holdings LLC in Albany, OR, a drug manufacturer, revealed significant deficiencies in its quality control unit, manufacturing process validation, and equipment qualification. The firm failed to test high-risk components, lacked stability data for expiration dates, and did not conduct annual product reviews or CGMP training. Additionally, the facility exhibited poor design and control, leading to potential cross-contamination and inadequate environmental monitoring.

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)
- [Jason K. Loo](https://www.keypedia.com/people/jason-k-loo/7977c92f-c40e-45af-a072-f84361045a47)

Company: https://www.keypedia.com/companies/dental-alliance-holdings-llc/98d94bab-654d-4bdc-b2e1-e43516bd1951

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913