# FDA 483 - Seqirus Inc - June 05, 2025

Source: https://www.keypedia.com/records/483/seqirus-inc/e8a3587e-efc6-409b-84c7-9cf11e02c14f

> FDA 483 for Seqirus Inc on June 05, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seqirus Inc
- Inspection Date: 2025-06-05
- Product Type: biologics
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: Seqirus Inc. in Holly Springs, NC, was inspected from May 28 to June 5, 2025, and received a Form 483 with two observations. The inspection revealed significant deficiencies in the firm's quality control unit, specifically regarding unwritten procedures for deviation management and a failure to ensure timely documentation and assessment of quality events. Additionally, the firm lacked adequate written procedures for production and process controls, particularly concerning material requests during electronic system outages.

## Related Documents

- [EIR - 2016-05-17](https://www.keypedia.com/records/eir/seqirus-inc/866e0ed8-0c41-46d8-a67e-8e2c852e1372)
- [483 - 2016-05-10](https://www.keypedia.com/records/483/seqirus-inc/b9e44a0e-ae9d-4457-99da-689211f16396)
- [483 - Unknown Date](https://www.keypedia.com/records/483/seqirus-inc/c9796008-bee5-4eb6-b934-10fddd796e7a)
- [EIR - 2022-06-09](https://www.keypedia.com/records/eir/seqirus-inc/ab9bbe9e-973c-4374-ab0f-fae1bdfdbf33)
- [483 - Unknown Date](https://www.keypedia.com/records/483/seqirus-inc/fc85c20f-111b-450c-ac9e-643a9be8b060)

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Investigator](https://www.keypedia.com/people/thai-d-truong/7395c128-0adb-44a1-8831-64673c98e93d)

Company: https://www.keypedia.com/companies/seqirus-inc/0debebe6-6f57-40d3-abf9-5914fb18b58a

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43