AGC Biologics A/S
Form 483 issued May 10, 2021 · Soeborg, Denmark
- Inspection
- May 3 – May 10, 2021
- Investigators
- Michael R. Shanks· Zhenzhen Liu
- Observations
- 2
- Pages
- 1
- FEI number
- 3004708748
In short: On May 10, 2021, FDA issued a Form 483 with 2 observations to AGC Biologics A/S in Soeborg, Denmark (FEI 3004708748) after an inspection that ran May 3 – May 10, 2021. The investigators were Michael R. Shanks and Zhenzhen Liu. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to assure that personnel have the necessary training in sample handling…
- 02
Change control regarding test method documents updates is not implemented in a timely manner to avoid…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmAGC Biologics A/S history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.25
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AGC Biologics A/S?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected AGC Biologics A/S?
Michael R. Shanks and Zhenzhen Liu are named on this Form 483, for the inspection of May 3 – May 10, 2021. Each investigator has a profile showing what they cite most.
When was AGC Biologics A/S inspected by FDA?
The inspection ran May 3 – May 10, 2021, and the Form 483 is dated May 10, 2021.
How do I get the full Form 483 for AGC Biologics A/S?
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.