# FDA 483 - HF Acquisition Co LLC - June 26, 2025

Source: https://www.keypedia.com/records/483/hf-acquisition-co-llc/61232fd8-b1f1-4f4f-aef0-d780d0975554

> FDA 483 for HF Acquisition Co LLC on June 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HF Acquisition Co LLC
- Inspection Date: 2025-06-26
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: An FDA inspection of HF Acquisition Co LLC dba HealthFirst in Mukilteo, WA, a drug repacker and relabeler, identified deficiencies within its quality control unit. The firm failed to demonstrate adequate document control over batch record documents and utilized an uncontrolled logbook for tracking drug product returns. These observations indicate a need for improved adherence to quality system procedures.

## Related Documents

- [483 - 2018-02-09](https://www.keypedia.com/records/483/hf-acquisition-co-llc/f47c6859-dc8c-440c-8cb0-0255ecad991e)

## Related Officers

- [Cecilia H. Kieu](https://www.keypedia.com/people/cecilia-h-kieu/3ba5feb0-d49e-4301-ae5c-b84bd604a159)
- [FDA_PERSONNEL](https://www.keypedia.com/people/aranjeet-singh/7359f43e-0e36-4cdd-a77d-3371d8b44b99)

Company: https://www.keypedia.com/companies/hf-acquisition-co-llc/779ad0f9-ddf8-469f-8801-2437c1a76993

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