# FDA 483 - Quest Products  LLC - November 07, 2024

Source: https://www.keypedia.com/records/483/quest-products-llc/53f5602e-5ec1-48e8-a0ae-11a3e164326a

> FDA 483 for Quest Products  LLC on November 07, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quest Products  LLC
- Inspection Date: 2024-11-07
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: Quest Products LLC, a manufacturer of finished drug products (tablets) in Kent, WA, was cited with six observations during an FDA inspection from October 30 to November 7, 2024. The inspection revealed significant deficiencies in process validation, quality control procedures, equipment qualification, cleaning validation, and batch record accuracy for their CankerMelts orally disintegrating drug tablet. These issues indicate a lack of adequate controls to assure drug product identity, strength, purity, and quality.

## Related Officers

- [Jason K. Loo](https://www.keypedia.com/people/jason-k-loo/7977c92f-c40e-45af-a072-f84361045a47)
- [issuing_officer](https://www.keypedia.com/people/michael-araneta/c94c95f4-2cda-43f5-a02a-2b5d82fe2c7d)

Company: https://www.keypedia.com/companies/quest-products-llc/07704679-8b71-46f6-bb2c-7992c061b86d

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