# FDA 483 - Spencer Specialty Products Inc - April 04, 2025

Source: https://www.globalkeysolutions.net/records/483/spencer-specialty-products-inc/3e419322-a846-4065-9374-b2f51d360586

> FDA 483 for Spencer Specialty Products Inc on April 04, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Spencer Specialty Products Inc
- Inspection Date: 2025-04-04
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: Spencer Specialty Products Inc, a drug manufacturer in Boise, ID, received four repeat observations during an FDA inspection. The firm demonstrated significant deficiencies in its quality system, including a non-existent quality control unit, inadequate raw material testing, and a lack of a stability testing program. Additionally, the facility failed to maintain adequate controls to prevent contamination and mix-ups in its production area.

## Related Officers

- [Bryan L. Mcguckin](https://www.globalkeysolutions.net/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

Company: https://www.globalkeysolutions.net/companies/spencer-specialty-products-inc/418dc32e-4ef3-4e34-87e6-730b9fb940be

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