# FDA 483 - BHC, LLC - June 30, 2023

Source: https://www.globalkeysolutions.net/records/483/bhc-llc/80286e12-1b4c-431a-9202-e15b48a9e44f

> FDA 483 for BHC, LLC on June 30, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BHC, LLC
- Inspection Date: 2023-06-30
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: BHC, LLC, an HCT/P processor and distributor in Brownsburg, IN, was cited for significant deficiencies related to donor eligibility, product labeling, and procedural controls during an FDA inspection. Observations included failures to properly determine donor eligibility, document physician notifications for ineligible donors, label biohazardous products, and establish adequate procedures for donor testing and product release. These issues indicate a lack of robust quality controls for human umbilical cord blood products.

## Related Officers

- [Lesley Mae P. Lutao](https://www.globalkeysolutions.net/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.globalkeysolutions.net/companies/bhc-llc/410f4cfa-94d7-4a0a-a845-2f15f2554255

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0