# FDA 483 - Stephens Instruments, Inc - October 26, 2023

Source: https://www.globalkeysolutions.net/records/483/stephens-instruments-inc/a4e571db-a0c2-4459-abf3-ef42fae0e2fd

> FDA 483 for Stephens Instruments, Inc on October 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Stephens Instruments, Inc
- Inspection Date: 2023-10-26
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Stephens Instruments, Inc., a medical device manufacturer in Lexington, KY, identified one observation. The firm's procedures for ensuring purchased products and services conform to specified requirements were found to be inadequate. This deficiency led to the approval of a contract medical device manufacturer that did not have an active registration on record.

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/stephens-instruments-inc/7104675f-7a59-42e0-ab76-799149a0f9ec

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