# FDA 483 - Charlotte Mecklenburg Hospital Authority dba Lifeshare Carolinas - May 18, 2023

Source: https://www.globalkeysolutions.net/records/483/charlotte-mecklenburg-hospital-authority-dba-lifeshare-carolinas/dfc8fe33-70ce-46a1-b34a-8390f25856ed

> FDA 483 for Charlotte Mecklenburg Hospital Authority dba Lifeshare Carolinas on May 18, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charlotte Mecklenburg Hospital Authority dba Lifeshare Carolinas
- Inspection Date: 2023-05-18
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: Charlotte Mecklenburg Hospital Authority dba LifeShare Carolinas received a Form 483 for deficiencies in its HCT/P manufacturing operations. The inspection revealed failures in environmental monitoring within the laminar flow hood, lack of demonstrated efficacy for disinfectants, and absence of written procedures for environmental monitoring. These issues indicate a lack of adequate controls to prevent contamination of human cells, tissues, and cellular and tissue-based products.

## Related Officers

- [Amy A. Johnson](https://www.globalkeysolutions.net/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

Company: https://www.globalkeysolutions.net/companies/charlotte-mecklenburg-hospital-authority-dba-lifeshare-carolinas/0ec99e24-0082-46da-b4ce-5664ae17fbb1

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7