FDA Inspection
Seqirus IncSeqirus Inc – FDA Inspection, Jun 5, 2025
Record Details
This FDA Inspection record concerns Seqirus Inc, with an inspection on June 5, 2025, issued by the Atlanta District Office, covering biologics.
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ID · 537b3437-a5d5-4d50-acfe-d5c5f30582d9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1271769
- FDA center
- Biologics
- Project area
- Vaccine, Allergenic, and Live Biotherapeutic Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Seqirus Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2022 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| June 18, 2018 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 17, 2016 | VAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| November 21, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Seqirus Inc
- FDA Inspection 1172982 - 2022-06-09
- FDA Inspection 1061837 - 2018-06-18
- FDA Inspection 968013 - 2016-05-17
- FDA Inspection 860576 - 2013-11-21
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