Seqirus Inc
Form 483 issued May 17, 2016 · Holly Springs, North Carolina
- Inspection
- May 10 – May 17, 2016
- Investigators
- Gene Arey· Nw W. Keller
- Observations
- 4
- Pages
- 3
- FEI number
- 3007867647
In short: On May 17, 2016, FDA issued a Form 483 with 4 observations to Seqirus Inc in Holly Springs, North Carolina (FEI 3007867647) after an inspection that ran May 10 – May 17, 2016. The investigators were Gene Arey and Nw W. Keller. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The following QA Investigations were initiated per SOP 303268, Processes and Responsibilities Relating to QA Investigations…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The following Events were…
- 04
The Product Impact Assessment for Deviation Event Report 307877, closed on (b)…
This inspection in context
Gene Arey
6 documents · 2015–2022
Cites 211.192 (production record review) 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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Seqirus Inc?
FDA listed 4 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Seqirus Inc?
Gene Arey and Nw W. Keller are named on this Form 483, for the inspection of May 10 – May 17, 2016. Each investigator has a profile showing what they cite most.
When was Seqirus Inc inspected by FDA?
The inspection ran May 10 – May 17, 2016, and the Form 483 is dated May 17, 2016.
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.