# FDA 483 - Seqirus Inc - Unknown Date

Source: https://www.keypedia.com/records/483/seqirus-inc/c9796008-bee5-4eb6-b934-10fddd796e7a

> FDA 483 for Seqirus Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seqirus Inc
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: Seqirus Inc. in Holly Springs, North Carolina, was cited for significant deficiencies in its influenza vaccine manufacturing processes. The inspection revealed inadequate control procedures for detecting particulates in pre-filled syringes, insufficient testing of critical raw materials like Squalene, and failures in sterility testing with unassigned root causes. These issues indicate a lack of robust quality control and process validation.

## Related Documents

- [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/fc85c20f-111b-450c-ac9e-643a9be8b060)
- [483 - 2025-06-05](https://www.keypedia.com/records/483/seqirus-inc/1666f05f-237c-42d5-af1f-203e6858bca0)

## Related Officers

- [company_representative](https://www.keypedia.com/people/wang-xia/00d972f9-dd57-4665-a95e-b16123ef85a3)
- [issuing_officer](https://www.keypedia.com/people/jean-hu-primmer/55300298-db2a-4ee9-b4cf-de5623c69013)
- [Haruhiko Murata](https://www.keypedia.com/people/haruhiko-murata/8e16e91c-7831-4519-8d5f-1c74f4485332)
- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

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

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1