# FDA 483 - Seqirus Inc - Unknown Date

Source: https://www.keypedia.com/records/483/seqirus-inc/fc85c20f-111b-450c-ac9e-643a9be8b060

> 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: Atlanta District Office
- Summary: Seqirus, Inc., an influenza vaccine manufacturer in Holly Springs, North Carolina, was cited for three observations during an FDA inspection. The firm failed to timely report serious unexpected adverse experiences and follow-up information. Additionally, the inspection revealed inadequate investigations into a power outage affecting classified areas and deficiencies in the quality control unit's procedures for classifying and initiating deviations.

## 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/c9796008-bee5-4eb6-b934-10fddd796e7a)
- [483 - 2025-06-05](https://www.keypedia.com/records/483/seqirus-inc/1666f05f-237c-42d5-af1f-203e6858bca0)

## Related Officers

- [investigator](https://www.keypedia.com/people/priscilla-m-pastrana/170080d1-49da-42d7-8615-c774cac9f7ec)
- [investigator](https://www.keypedia.com/people/susan-m-jackson/2a4e01d1-8761-4d40-b493-69a4163473bb)
- [Jeremy Webb, Senior Advisor](https://www.keypedia.com/people/jeremy-webb-senior-advisor/819bcd20-3e26-44f5-a23e-0b9da23ca200)

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

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7