# FDA 483 - Spinergy, Inc (SM Power LLC) - August 15, 2023

Source: https://www.keypedia.com/records/483/spinergy-inc-sm-power-llc/366c4674-2346-4c81-a085-b464b4678fab

> FDA 483 for Spinergy, Inc (SM Power LLC) on August 15, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Spinergy, Inc (SM Power LLC)
- Inspection Date: 2023-08-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Spinergy, Inc (SM Power LLC), a Class II medical device manufacturer in San Marcos, CA, revealed significant deficiencies in their quality system. Observations included a lack of written Medical Device Reporting (MDR) procedures, inadequate equipment calibration, and insufficient documentation for corrective and preventive actions. Additionally, device history records were found to be incomplete, failing to meet device master record requirements.

## Related Documents

- [483 - 2023-08-15](https://www.keypedia.com/records/483/spinergy-inc-sm-power-llc/51d8c066-bf76-496f-99a6-47428f362d9a)

## Related Officers

- [Kelvin Cheung](https://www.keypedia.com/people/kelvin-cheung/ded61aee-4b4b-4049-a67c-19d971475be7)

Company: https://www.keypedia.com/companies/spinergy-inc-sm-power-llc/a488779c-ba96-42ca-9fe4-29409550d6b1

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6