# FDA 483 - IT Synergistics, LLC - June 23, 2020

Source: https://www.globalkeysolutions.net/records/483/it-synergistics-llc/aa5ee89d-969c-416a-9700-d7184245f206

> FDA 483 for IT Synergistics, LLC on June 23, 2020. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IT Synergistics, LLC
- Inspection Date: 2020-06-23
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: IT Synergistics, LLC, a manufacturer of blood establishment computer software in Flowood, MS, was cited with 10 observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, particularly concerning complaint handling, CAPA, design controls, management review, and quality audits for its LifeTec Elite and DoVac Elite software products. These issues indicate a fundamental lack of established procedures and oversight for critical quality system elements.

## Related Officers

- [Cody D. Rickman](https://www.globalkeysolutions.net/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)

Company: https://www.globalkeysolutions.net/companies/it-synergistics-llc/b431de05-ceac-4e64-b651-283904dea19e

Office: https://www.globalkeysolutions.net/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea