# FDA 483 - Custom Healthcare Systems of VA, LLC - September 04, 2019

Source: https://www.globalkeysolutions.net/records/483/custom-healthcare-systems-of-va-llc/1689c5a7-362d-4522-a006-9ace0aa71850

> FDA 483 for Custom Healthcare Systems of VA, LLC on September 04, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom Healthcare Systems of VA, LLC
- Inspection Date: 2019-09-04
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: Custom Healthcare Systems, Inc. in Richmond, VA, a medical device manufacturer, received a Form FDA-483 citing four significant quality system deficiencies. The observations included a lack of documented justification for not reporting a medical device recall, inadequate supplier qualification for sterilization services (a repeat observation), and failures in incoming product acceptance procedures and internal quality audits. These findings highlight critical areas for improvement in the firm's adherence to regulatory requirements.

## Related Documents

- [483 - 2022-10-26](https://www.globalkeysolutions.net/records/483/custom-healthcare-systems-of-va-llc/788c1344-e794-48ab-856a-d0a3795b54b9)

## Related Officers

- [Investigato](https://www.globalkeysolutions.net/people/joey-c-west/4ecce3be-9f8f-40eb-a7ff-0364f5864bfa)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e