AGC Biologics A/S
Form 483 issued November 5, 2019 · Soeborg, Denmark
- Inspection
- Oct 28 – Nov 5, 2019
- Investigators
- Amy Hsu· Reyes Candau-Chacon· Riley Myers
- Observations
- 8
- Pages
- 4
- FEI number
- 3004708748
In short: On November 5, 2019, FDA issued a Form 483 with 8 observations to AGC Biologics A/S in Soeborg, Denmark (FEI 3004708748) after an inspection that ran Oct 28 – Nov 5, 2019. The investigators were Amy Hsu, Reyes Candau-Chacon and Riley Myers. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and quality system account for 6 of 8 observations.
Most cited: 21 CFR 211.192 (3×) · 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing steps not included in the master batch records (MBR) are conducted without approval…
- 02
(ONC) ‘Adequate procedures for allocation of equipment and material prior to initiation of drug substance manufacture…
- 03
Batch records are not documented following the…
- 04
Quality Assurance failed to…
This inspection in context
Amy Hsu
1 document · 2019
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Denmark.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AGC Biologics A/S?
FDA listed 8 observations on this Form 483, mostly about production, quality system and laboratory controls. 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 AGC Biologics A/S?
Amy Hsu, Reyes Candau-Chacon and Riley Myers are named on this Form 483, for the inspection of Oct 28 – Nov 5, 2019. Each investigator has a profile showing what they cite most.
When was AGC Biologics A/S inspected by FDA?
The inspection ran Oct 28 – Nov 5, 2019, and the Form 483 is dated November 5, 2019.
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.