# FDA 483 - LifeSouth Community Blood Centers, Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/lifesouth-community-blood-centers-inc/9fe1dec7-454d-4715-998f-20ad17e35deb

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

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## Details

- Record Type: 483
- Company Name: LifeSouth Community Blood Centers, Inc
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of LIFESouth Community Blood Center, a cord blood processor in Gainesville, Florida, revealed significant deficiencies across its quality system. Observations included failures to report major product label changes, lack of ongoing stability data for cord blood units, and an inadequate change control program. The firm also lacked proper contractual agreements with service providers, had deficient Standard Operating Procedures, and exhibited insufficient employee training in critical operations.

## Related Documents

- [483 - 2018-07-24](https://www.globalkeysolutions.net/records/483/lifesouth-community-blood-centers-inc/74eb86f0-4cfd-4582-9a59-c27e4e92836f)
- [483 - 2020-02-27](https://www.globalkeysolutions.net/records/483/lifesouth-community-blood-centers-inc/17812fbf-51ac-42d6-b4de-ff8f31b86ce8)

## Related Officers

- [National Expert, Pharmaceutical](https://www.globalkeysolutions.net/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)
- [investigator](https://www.globalkeysolutions.net/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1