# FDA EIR - Patheon Biologics LLC - March 02, 2023

Source: https://www.keypedia.com/records/eir/patheon-biologics-llc/be1b1e64-d9a3-4c83-b83c-13437f976c68

> FDA EIR for Patheon Biologics LLC on March 02, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Patheon Biologics LLC
- Inspection Date: 2023-03-02
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA surveillance inspection of Patheon Biologics LLC, a drug substance manufacturer in Saint Louis, MO, was conducted from February 22 to March 2, 2023. This cGMP inspection, focusing on biological drug substances and cell banking operations under Compliance Program 7356.002M, covered Quality, Laboratory, Facility, Equipment, Materials, and Production systems.The inspection revealed four significant findings documented in an FDA Form-483. Primary violations included inadequate protection of laboratory control records, where data from critical analytical instruments lacked safeguards against manipulation or deletion. There was also an absence of procedures for appropriately managing manual data integration within chromatography systems, with numerous instances observed lacking proper explanation.Further issues comprised insufficient investigation records for critical deviations and out-of-specification results, specifically noting inadequate root cause determinations. The firm also failed to ensure the quality of critical incoming raw materials through comprehensive testing. Lastly, equipment maintenance was deficient, highlighted by a lack of routine calibration and adherence to qualified operating ranges for a Controlled Rate Freezer.Patheon Biologics LLC's management stated they would submit a written response to the FDA's observations within 15 business days.

## Related Documents

- [483 - 2023-11-10](https://www.keypedia.com/records/483/patheon-biologics-llc/3d352468-eb8e-489c-aaf9-7814b0230ae4)
- [483 - 2023-12-08](https://www.keypedia.com/records/483/patheon-biologics-llc/6a07cddb-6465-45e2-9964-326e00b3b830)
- [483 - 2023-03-02](https://www.keypedia.com/records/483/patheon-biologics-llc/0cec7e64-81ac-40a0-bcb4-b82ea16daeba)
- [EIR - 2019-08-02](https://www.keypedia.com/records/eir/patheon-biologics-llc/35caa8c6-9f70-4411-9b43-028267777ca4)
- [EIR - 2023-11-10](https://www.keypedia.com/records/eir/patheon-biologics-llc/17b3c6b9-a62c-4cf6-8567-bbafecbcb8e8)

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [company_representative](https://www.keypedia.com/people/tyler-leach/355be499-1319-41f2-b218-f08d3c00208e)
- [company_representative](https://www.keypedia.com/people/susan-lacey/51e54cd6-0873-46e9-8d80-993d13398866)
- [company_representative](https://www.keypedia.com/people/jamie-istre/7840dafe-9966-47c9-be95-924b796df50d)
- [company_representative](https://www.keypedia.com/people/ashley-peters/8c4082fd-b9a2-449f-8fcd-ef31a413df28)

Company: https://www.keypedia.com/companies/patheon-biologics-llc/f1012be8-80da-4749-b923-0c97e2b6d47f

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