# FDA 483 - Signal Medical Corporation - April 10, 2023

Source: https://www.globalkeysolutions.net/records/483/signal-medical-corporation/cecb6e22-08d4-4d4d-ba03-530bda2e5fc3

> FDA 483 for Signal Medical Corporation on April 10, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Signal Medical Corporation
- Inspection Date: 2023-04-10
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: Signal Medical Corporation in Marysville, MI, a medical device establishment, was cited for multiple quality system deficiencies during an FDA inspection. Observations included inadequate statistical techniques for process control, design history files not conforming to current design control procedures and 21 CFR 820, and failures in monitoring critical suppliers. Additionally, the firm lacked adequate training procedures, specifically for key personnel involved in device recalls.

## Related Documents

- [WARNING_LETTER - 2014-08-11](https://www.globalkeysolutions.net/records/warning_letter/signal-medical-corporation/52391edb-84c9-4ef1-aa44-4084ba9efbef)

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/signal-medical-corporation/6995f522-0aba-4239-8317-5f6667e624c3

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0