# FDA 483 - G Surgical LLC - March 01, 2023

Source: https://www.keypedia.com/records/483/g-surgical-llc/e053972e-b626-4436-b9a6-58286cb125d6

> FDA 483 for G Surgical LLC on March 01, 2023. Product: devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: G Surgical LLC
- Inspection Date: 2023-03-01
- Product Type: devices
- Office Name: Dallas District Office
- Summary: G Surgical LLC, a medical device manufacturer in Austin, TX, underwent an FDA inspection from February 27 to March 1, 2023. The inspection, documented in a Form FDA 483, identified one critical observation related to the company's quality system. The main violation was the failure to establish and maintain procedures for the acceptance of incoming raw materials and components. Specifically, investigators found that G Surgical LLC did not have any documentation showing inspections of incoming materials had been completed since 2019, despite having a written procedure (QP-15, Rev 1) requiring such actions. This lapse indicates a significant gap in their quality control processes for verifying raw material quality. This observation falls under the regulatory framework of the Federal Food, Drug, and Cosmetic Act, which mandates adherence to quality system requirements. While the FDA 483 itself is an observation and not a final determination, it signifies that corrective actions are required. G Surgical LLC acknowledged the observation and committed to correcting the deficiency, necessitating the implementation of robust measures to ensure consistent inspection and documentation of all incoming materials to meet regulatory standards.

## Related Documents

- [483 - 2023-03-01](https://www.keypedia.com/records/483/g-surgical-llc/afec050b-4b90-42b3-b06c-70fb2afe4315)
- [EIR - Unknown Date](https://www.keypedia.com/records/eir/g-surgical-llc/e08545a5-2ff9-498e-9965-c01464f5fc26)

## Related Officers

- [investigator](https://www.keypedia.com/people/olalere-d-fasipe/0dd0f0ae-07d9-40ab-b602-97521150d23d)

Company: https://www.keypedia.com/companies/g-surgical-llc/d59827eb-20f0-479c-a8e4-b419d229ce21

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9