# FDA 483 - BioIntegrate Inc - July 18, 2023

Source: https://www.keypedia.com/records/483/biointegrate-inc/02ac8f0f-d334-4520-a116-52738855d7a3

> FDA 483 for BioIntegrate Inc on July 18, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioIntegrate Inc
- Inspection Date: 2023-07-18
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: BioIntegrate Inc, a relabeler/manufacturer in Morrow, GA, was inspected by the FDA from July 10-18, 2023. The inspection revealed significant deficiencies in quality control, including failure to test drug products before release, inadequate investigations into discrepancies, and improper donor eligibility determinations for HCT/P products. The firm also lacked proper labeling controls, batch production records, stability data for expiration dates, annual product reviews, and reserve sample procedures, indicating a broad lack of adherence to good manufacturing practices.

## Related Officers

- [Cody D. Rickman](https://www.keypedia.com/people/cody-d-rickman/54deec25-dc65-4402-991a-ad5589bad78b)

Company: https://www.keypedia.com/companies/biointegrate-inc/1a2a943e-313f-4268-8bd5-89ba053d663c

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