# FDA 483 - Precision Edge Surgical Products Co. LLC. - November 20, 2025

Source: https://www.keypedia.com/records/483/precision-edge-surgical-products-co-llc/8cde0b34-c66e-41e2-a138-ce3208f22e9c

> FDA 483 for Precision Edge Surgical Products Co. LLC. on November 20, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Precision Edge Surgical Products Co. LLC.
- Inspection Date: 2025-11-20
- Product Type: device
- Office Name: Detroit District Office
- Summary: Precision Edge Surgical Products Co. LLC in Boyne City, MI, was issued a Form 483 with two observations following an FDA inspection. The firm's process validation for its medical device (b)(4) System was found inadequate, with operations occurring outside validated parameters and insufficient process characterization. Additionally, the company failed to establish and implement adequate training procedures for personnel involved in nonconformance identification and quality inspections.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/precision-edge-surgical-products-co-llc/88bc61e6-2fe0-4e95-b469-154b98941432

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03