# LifeSouth Community Blood Centers, Inc – FDA 483, Jul 24, 2018

Source: https://www.keypedia.com/records/483/lifesouth-community-blood-centers-inc/74eb86f0-4cfd-4582-9a59-c27e4e92836f

> FDA 483 for LifeSouth Community Blood Centers, Inc on July 24, 2018. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LifeSouth Community Blood Centers, Inc
- Inspection Date: 2018-07-24
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Lifesouth Community Blood Centers, Inc. in Gainesville, FL, a cord blood manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. Observations included a repeat finding for inadequate reserve samples, failures in deviation reporting and investigation, lack of Quality Control Unit authority and written procedures, and poor computer system controls. The firm also had issues with environmental monitoring, laboratory controls for media growth promotion, aseptic cleaning, and product labeling.

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## Related Officers

- [Research Specialist II](https://www.keypedia.com/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Mercy O Quagraine](https://www.keypedia.com/people/mercy-o-quagraine/c199b205-0142-43a0-ac9e-965aabf42265)
- [investigator](https://www.keypedia.com/people/jacqueline-m-diaz-albertini/9ff937fe-4e9b-445a-80fa-e26800d923b8)

Company: https://www.keypedia.com/companies/lifesouth-community-blood-centers-inc/94ebe4e9-b648-4d51-a063-4ad00b617893

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6