FDA 483 - Assurance Infusion - December 03, 2019

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