# FDA 483 - Assurance Infusion - December 03, 2019

Source: https://www.keypedia.com/records/483/assurance-infusion/e1365ae0-577b-4162-9736-5416bc26d00f

> 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: This FDA Form 483 documents observations from an inspection, highlighting several deficiencies in the firm's manufacturing and quality control processes for sterile drug products, particularly intrathecal formulations.

**Key Violations and Observations:**

*   **Lack of Endotoxin Testing:** The firm does not test any lots of intrathecal drug products for endotoxin prior to release, despite using non-sterile bulk drugs. Approximately (b)(4) lots of intrathecal products were dispensed without endotoxin testing in the last 12 months.
*   **Unsubstantiated Beyond Use Dates (BUD):**
    *   A nine-day BUD for intrathecal drug products lacks supporting data.
    *   A 90-day BUD for intrathecal stock solutions (e.g., Hydromorphone HCl) is not supported by sterility testing data.
*   **Sterility Sample Turbidity/Precipitate:** Turbidity and/or precipitate were noted in sterility samples for Tri-Mix lots #11112019@9, #11112019@10, and #11112019@21, with no investigation performed to date.
*   **Aseptic Processing Deficiencies:**
    *   An operator failed to re-sanitize gloved hands after retrieving supplies outside the ISO 5 area and re-entering.
    *   The

## Related Documents

- [483 - 2019-12-03](https://www.keypedia.com/records/483/assurance-infusion/c2d1eb10-2fdb-40fd-a1d4-12c95210a5b9)

## 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