# FDA 483 - Aurohealth LLC - April 11, 2019

Source: https://www.keypedia.com/records/483/aurohealth-llc/f26e92cd-dc15-4e6c-828a-105e5f709bee

> FDA 483 for Aurohealth LLC on April 11, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Aurohealth LLC
- Inspection Date: 2019-04-11
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: An FDA inspection of Aurohealth LLC in Lawrence Township, NJ, revealed significant deficiencies in equipment calibration and cleaning validation. The firm failed to ensure scales were appropriately calibrated for weighing raw materials and lacked adequate cleaning procedures and validation for manufacturing equipment, including transfer hoses. These issues raise concerns about the accuracy of drug product formulation and the prevention of cross-contamination.

## Related Officers

- [Johnna L. Bleem](https://www.keypedia.com/people/johnna-l-bleem/3fe669bf-e354-4cdc-9337-d5ceb23f1c9f)
- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/aurohealth-llc/c20201d7-26bf-46b9-8284-91b7caa49ba7

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248