# FDA 483 - HTO Nevada Inc - August 22, 2025

Source: https://www.keypedia.com/records/483/hto-nevada-inc/489eb225-eee5-499e-9844-f959420f8584

> FDA 483 for HTO Nevada Inc on August 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HTO Nevada Inc
- Inspection Date: 2025-08-22
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: HTO Nevada Inc. dba Kirkman, a contract drug manufacturer in Lake Oswego, OR, received an FDA Form 483 with eight observations. The inspection revealed significant deficiencies in quality control, stability testing, process validation, and labeling, including repeat observations related to inadequate investigations, quality unit procedures, and annual product reviews. These issues indicate a lack of robust controls to ensure drug product identity, strength, purity, and quality.

## Related Documents

- [483 - 2025-08-22](https://www.keypedia.com/records/483/hto-nevada-inc/bed8f068-8fa7-45a5-bea9-4ae8830ea059)

## Related Officers

- [Nathan E. Hellman](https://www.keypedia.com/people/nathan-e-hellman/88dc6c17-72bf-4c2c-a952-a4ebcd742142)
- [Statistical Science Director](https://www.keypedia.com/people/anney-lin/e1dc45a5-a28f-4636-be13-e9bee6f3bc4e)

Company: https://www.keypedia.com/companies/hto-nevada-inc/c42bc0ec-4d68-4db5-8860-0f6c8e248c99

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822