Seqirus

United States Updated 9 July 2026

Seqirus is a finished-dose manufacturer based in United States. It appears in 316 regulatory filings across 13 regulators, without an active US DMF or CEP on file. Its filings concentrate with MEDSAFE (NZ), Health Canada and EMA. Its GMP standing is certified by ANVISA (Brazil), MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 5 June 2025 as VAI.

active US DMFs

valid CEPs

registered plants 1 with an FDA FEI number

316

filings across 13 regulators

These figures were checked against the regulators' own files on 25 July 2026

Plants

1 of 1 confirmed

Inspections

5 of 5 confirmed

Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

5 June 2025 VAI US FDA
9 June 2022 VAI US FDA
18 June 2018 VAI US FDA
17 May 2016 VAI US FDA
21 November 2013 NAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site	FDA FEI
MAIDENHEAD, United Kingdom	Not on file
NORTH CAROLINA, United States	Not on file
Holly Springs, United States	3007867647

Filings and GMP by regulator

Regulator	Filings	GMP certificates
MEDSAFE (NZ)	168	None
Health Canada	39	None
EMA	31	None
FAMHP (BE)	20	None
MPA (SE)	16	None
AIFA (IT)	15	None
ANVISA (Brazil)	None	2
MHRA (UK)	None	2
US FDA	None	1

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Open risk flags

The most recent inspection outcome was VAI, on 5 June 2025.

Sources on this page

FDA: Drug master files, establishment registration, inspection classifications
EDQM: Certificates of suitability
EudraGMDP and national regulators: GMP certificates