# FDA 483 - Spectramed LLC - October 26, 2022

Source: https://www.keypedia.com/records/483/spectramed-llc/405183ec-11ba-421e-9ac4-538de3fe62f0

> FDA 483 for Spectramed LLC on October 26, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Spectramed LLC
- Inspection Date: 2022-10-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Spectramed LLC, a medical device specification developer in Columbus, OH, identified two observations. The firm failed to adequately document the evaluation of potential suppliers and did not ensure that employees used current revisions of approved documents. These issues indicate deficiencies in the firm's quality system regarding purchasing and document controls.

## Related Officers

- [Medical Device Specialist](https://www.keypedia.com/people/rosanna-m-goodrich/44c5c743-f67b-41fe-9cd1-8b5913bf580e)

Company: https://www.keypedia.com/companies/spectramed-llc/6cd71eb5-3aa5-4e94-ac4f-d13b815d2ced

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22