FDA Intel

Seqirus Inc

Form 483 issued June 9, 2022 · Holly Springs, North Carolina

Observations
3
Pages
3
FEI number
3007867647

In short: On June 9, 2022, FDA issued a Form 483 with 3 observations to Seqirus Inc in Holly Springs, North Carolina (FEI 3007867647). Most observations concern quality system and biologics CGMP.

At a glance

2 of 3 observations on this 483 concern quality system.

Quality system2
Biologics CGMP1

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01
    21 CFR 600.80

    Adverse experience information was not reported…

  2. 02
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…

  3. 03
    21 CFR 211.22

    The responsibilities and procedures applicable to the quality control unit…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Seqirus Inc history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 600.80

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 quality system and biologics CGMP. The opening words of each observation are shown on this page.

When was Seqirus Inc inspected by FDA?

This Form 483 is dated June 9, 2022.

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.

$99Get it free