# FDA 483 - LabCorp Indiana Inc. - July 13, 2021

Source: https://www.globalkeysolutions.net/records/483/labcorp-indiana-inc/a58661df-25bb-4c2b-ab1d-b6893677222b

> FDA 483 for LabCorp Indiana Inc. on July 13, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LabCorp Indiana Inc.
- Inspection Date: 2021-07-13
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of LabCorp Indiana Inc. in South Bend, IN, revealed a critical deficiency in their quality program. The firm failed to properly investigate, document, and report multiple malfunctions of an analyzer used for HCT/P sterility testing, impacting donor eligibility determinations. This indicates a serious lapse in adherence to core Current Good Tissue Practice (CTGP) requirements for deviation management.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/jennifer-a-kemp/51aa8f2f-ba64-47d3-aa06-b4595b3d15c8)
- [issuing_officer](https://www.globalkeysolutions.net/people/matthew-j-gretkierewicz/d2b43230-5324-44e0-9cd0-7e40464bf5b0)

Company: https://www.globalkeysolutions.net/companies/labcorp-indiana-inc/68786bd2-5ce6-425b-8701-993d25058afb

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