# FDA 483 - BioDlogics LLC - August 08, 2019

Source: https://www.keypedia.com/records/483/biodlogics-llc/d7307f13-a448-4237-aae3-bb0228b14366

> FDA 483 for BioDlogics LLC on August 08, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BioDlogics LLC
- Inspection Date: 2019-08-08
- Product Type: biologics
- Office Name: New Orleans District Office
- Summary: BioLogics LLC, an HCT/P manufacturer in Cordova, TN, was cited for significant deficiencies during an FDA inspection. Observations included failure to validate sterilization processes for Amniotic Membrane HCT/Ps, inadequate complaint handling procedures to identify adverse event trends, and failure to report a serious adverse reaction involving a communicable disease to the FDA. These issues indicate a lack of robust quality control and regulatory compliance.

## Related Officers

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

Company: https://www.keypedia.com/companies/biodlogics-llc/4fc091e0-d7f2-44fc-ba70-4d37fdd16f03

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea