# FDA 483 - RXQ Compounding LLC - September 21, 2015

Source: https://www.keypedia.com/records/483/rxq-compounding-llc/30dff3d1-6e42-415e-bf2b-72ded6ad6166

> FDA 483 for RXQ Compounding LLC on September 21, 2015. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RXQ Compounding LLC
- Inspection Date: 2015-09-21
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: The FDA inspection of an outsourcing facility revealed multiple deficiencies in aseptic processing, quality control, and record-keeping.

**Aseptic Processing Deficiencies:**
*   **Air Supply:** A smoke study of the ISO 7 clean room and ISO 5 hood showed smoke egress, indicating a deficient air supply system. Two sterile products, IC-Green 6.25mg/ml Ophthalmic Solution lot#08132015@1 (distributed) and Acetaminophen 10mg/ml Injectable lot#08212015@7 (on sterility test hold), were processed in the affected ISO 5 hood.
*   **Environmental Monitoring:** The firm failed to frequently monitor differential pressure readings during aseptic production.
*   **Sterilization Process Validation:**
    *   Media fills for ISO 5 hood personnel did not simulate actual production or challenging conditions, specifically lacking a media fill for the (b)(4) sterilization method used for Acetaminophen 10mg/ml Injectable.
    *   A (b)(4) used for (b)(4) sterilization of Acetaminophen 10mg/ml Injectable lot#08212015@7 was labeled "For research use only, not for in vitro diagnostic or for parenterals."
    *   Depyrogenation validation for finished product vials and (b)(4) sterilization of stoppers, tools,

## Related Documents

- [483 - 2017-08-08](https://www.keypedia.com/records/483/rxq-compounding-llc/cb119fc7-e9ab-4848-b6db-ae146b5dc67e)

## Related Officers

- [Senior Director Technical](https://www.keypedia.com/people/christopher-t-middendorf/0fea23f5-ffe6-49a0-ac33-780317707c71)
- [Investigator](https://www.keypedia.com/people/joshua-p-wireman/1f5cca58-4a35-4b1a-b344-35820b1e58fb)

Company: https://www.keypedia.com/companies/rxq-compounding-llc/50376587-fdbd-435b-86ea-c5cc94d5c260

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22