# FDA 483 - Custom Healthcare Systems of VA, LLC - October 26, 2022

Source: https://www.globalkeysolutions.net/records/483/custom-healthcare-systems-of-va-llc/788c1344-e794-48ab-856a-d0a3795b54b9

> FDA 483 for Custom Healthcare Systems of VA, LLC on October 26, 2022. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom Healthcare Systems of VA, LLC
- Inspection Date: 2022-10-26
- Product Type: other
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Custom Healthcare Systems of VA, LLC in Richmond, VA, a medical device manufacturer, revealed two significant quality system deficiencies. The firm failed to adequately establish and implement sampling procedures, using an outdated sampling standard and not following its own procedures for finished product sampling. Additionally, the company did not perform required internal quality audits at defined intervals during 2020 and 2021.

## Related Documents

- [483 - 2019-09-04](https://www.globalkeysolutions.net/records/483/custom-healthcare-systems-of-va-llc/1689c5a7-362d-4522-a006-9ace0aa71850)

## Related Officers

- [Tiki Dixon](https://www.globalkeysolutions.net/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.globalkeysolutions.net/companies/custom-healthcare-systems-of-va-llc/9685f661-d34d-48ba-88c1-956ac94ae258

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64