# FDA EIR - PetNet Solutions Inc - April 08, 2022

Source: https://www.keypedia.com/records/eir/petnet-solutions-inc/c30b8cb6-c8e1-47a9-89d7-be9aa2e79bac

> FDA EIR for PetNet Solutions Inc on April 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: PetNet Solutions Inc
- Inspection Date: 2022-04-08
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: During an FDA pre-approval inspection of PETNET Solutions Inc.'s Elk Grove Village, IL facility from April 5-8, 2022, two significant observations were identified and discussed with management, though no formal inspectional observations (Form FDA 483) were issued. The inspection was conducted under Compliance Program 7356.002P, focusing on Positron Emission Tomography (PET) drug Current Good Manufacturing Practices (CGMP) and pre-approval requirements for the Axumin (Fluciclovine F-18 Injection) drug product. The primary issues involved deficiencies in manufacturing documentation and equipment traceability. Firstly, critical manufacturing steps, specifically the addition and type of filter used to transfer Axumin from an intermediate container to the final product vial, were not adequately documented in the batch production record. Secondly, media fill records lacked specific incubator equipment identification, preventing full traceability to the incubation conditions. PETNET Solutions Inc. management acknowledged these findings and committed to implementing corrective actions. A Corrective and Preventive Action (CAPA) plan was initiated by the firm to address the batch record documentation issue.

## Related Documents

- [483 - 2025-08-06](https://www.keypedia.com/records/483/petnet-solutions-inc/ef7bd977-35be-43de-8c7f-01e8fd6fc613)

## Related Officers

- [Brian D. Nicholson](https://www.keypedia.com/people/brian-d-nicholson/83ea13dd-6753-468a-a0ca-19e3ef4158dd)

Company: https://www.keypedia.com/companies/petnet-solutions-inc/2b0bf115-a724-4d4b-bee1-be8923a5bb5b

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669