# FDA 483 - Seqirus Inc - May 10, 2016

Source: https://www.keypedia.com/records/483/seqirus-inc/b9e44a0e-ae9d-4457-99da-689211f16396

> FDA 483 for Seqirus Inc on May 10, 2016. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seqirus Inc
- Inspection Date: 2016-05-10
- Product Type: biologics
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Seqirus Inc. (A CSL Company) in Holly Springs, NC, a licensed biological (vaccine) manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate documentation for QA investigations into serious adverse events, improper change control classification for an SOP update, and misclassification of critical occurrences as 'Events' instead of 'Deviations'. These issues indicate a lack of robust processes for ensuring product quality, safety, and efficacy.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Paul W. Keller, Staff Fellow](https://www.keypedia.com/people/paul-w-keller-staff-fellow/2d31b1de-d103-46e6-8944-78681e90c9df)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)
- [Steven A. Rubin, Supervisory Microbiologist](https://www.keypedia.com/people/steven-a-rubin-supervisory-microbiologist/dd97d6c0-26b8-42bb-9275-71e13012388e)

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