# FDA 483 - Production Systems Inc - March 12, 2026

Source: https://www.keypedia.com/records/483/production-systems-inc/f3ce37f7-70a5-4a80-a082-0e685d047e12

> FDA 483 for Production Systems Inc on March 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Production Systems Inc
- Inspection Date: 2026-03-12
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Production Systems, Inc. in Shoreview, MN, a manufacturer of cables and adaptors for electrosurgical devices, revealed a significant deficiency in their quality system. The firm failed to adequately document its risk management processes for product realization. This included a lack of documented risk management plans, hazard identification records, risk evaluation records, risk control measures, residual risk justifications, and risk management reports.

## Related Officers

- [Alicia U. Jacobo](https://www.keypedia.com/people/alicia-u-jacobo/5f75a995-c0df-4615-be88-d401df48ad26)

Company: https://www.keypedia.com/companies/production-systems-inc/d7f741b3-f005-4d96-a7cc-1214dbb1f40b

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d