# FDA 483 - Far East Summit LLC - April 18, 2025

Source: https://www.keypedia.com/records/483/far-east-summit-llc/29a7ee13-0b33-402a-859a-9b153ab66652

> FDA 483 for Far East Summit LLC on April 18, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Far East Summit LLC
- Inspection Date: 2025-04-18
- Product Type: other
- Office Name: Seattle District Office
- Summary: Far East Summit LLC received a Form 483 with 22 observations detailing significant deficiencies in its dietary supplement manufacturing operations. The firm failed to establish adequate product and component specifications, conduct proper identity testing, and qualify suppliers, with several issues being repeat observations. Key concerns include unqualified quality control personnel, inadequate master and batch manufacturing records, poor hygienic practices, and a lack of effective controls against foreign material contamination.

## Related Documents

- [WARNING_LETTER - 2024-02-14](https://www.keypedia.com/records/warning_letter/far-east-summit-llc/0967b5fe-22fc-4948-ae08-a4c81f256635)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/jean-c-colon-lopez/0ccff22e-b08e-4579-977b-c2ac64ccaa35)
- [Gary C. Pecic](https://www.keypedia.com/people/gary-c-pecic/37cf1f4d-6b1c-4be6-8adb-89cf685f5022)

Company: https://www.keypedia.com/companies/far-east-summit-llc/cf894bbe-91e2-4084-82b6-f5d8ba3e3d23

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