# FDA 483 - The Peavey Corporation dba Lynn Peavey Co. - January 10, 2023

Source: https://www.keypedia.com/records/483/the-peavey-corporation-dba-lynn-peavey-co/031ad7a7-62ac-4937-81db-9082c81d6733

> FDA 483 for The Peavey Corporation dba Lynn Peavey Co. on January 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: The Peavey Corporation dba Lynn Peavey Co.
- Inspection Date: 2023-01-10
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: The Peavey Corporation dba Lynn Peavey Co. in Lenexa, KS, was inspected and cited for significant deficiencies in its quality system. Observations include a lack of process validation for sterilization, inadequate purchasing controls, undocumented personnel training, and the absence of internal quality audits and management reviews. These issues indicate a broad failure to establish and implement essential quality system procedures for medical device manufacturing.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/the-peavey-corporation-dba-lynn-peavey-co/f06663c6-36ed-45af-8333-385702f27355

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8