# FDA 483 - Assurance Infusion - December 03, 2019

Source: https://www.keypedia.com/records/483/assurance-infusion/c2d1eb10-2fdb-40fd-a1d4-12c95210a5b9

> FDA 483 for Assurance Infusion on December 03, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Assurance Infusion
- Inspection Date: 2019-12-03
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Nanobots Healthcare, LLC dba Assurance Infusion, a producer of sterile drug products, revealed significant deficiencies in their manufacturing processes. Observations included a lack of endotoxin and sterility testing for intrathecal products, inadequate aseptic processing controls, and unverified depyrogenation and calibration procedures. These issues indicate a serious risk to the sterility and quality of their drug products.

## Related Documents

- [483 - 2019-12-03](https://www.keypedia.com/records/483/assurance-infusion/e1365ae0-577b-4162-9736-5416bc26d00f)

## Related Officers

- [Principal Consultant](https://www.keypedia.com/people/stephen-d-brown/01ff1439-f6d7-4501-a104-573dae30d306)

Company: https://www.keypedia.com/companies/assurance-infusion/ea04c13f-472a-4ba6-a662-e2d88271a0a4

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9