Seqirus Inc
Form 483 issued June 18, 2018 · Holly Springs, North Carolina
- Investigators
- Haruhiko Murata· Jean Hu-Primmer
- Observations
- 3
- Pages
- 4
- FEI number
- 3007867647
In short: On June 18, 2018, FDA issued a Form 483 with 3 observations to Seqirus Inc in Holly Springs, North Carolina (FEI 3007867647). The investigators were Haruhiko Murata and Jean Hu-Primmer. Most observations concern production and materials.
At a glance
Production and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Control Procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Haruhiko Murata
2 documents · 2015–2018
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in North Carolina.
The firmSeqirus Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Seqirus Inc?
FDA listed 3 observations on this Form 483, mostly about production, materials and quality system. The opening words of each observation are shown on this page.
Who inspected Seqirus Inc?
Haruhiko Murata and Jean Hu-Primmer are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Seqirus Inc inspected by FDA?
This Form 483 is dated June 18, 2018.
How do I get the full Form 483 for Seqirus Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.