AstraZeneca Nijmegen B.V.
Form 483 issued September 19, 2019 · Nijmegen, Netherlands
- Inspection
- Sep 12 – Sep 19, 2019
- Investigator
- Thuy T. Nguyen
- Observations
- 2
- Pages
- 1
- FEI number
- 3003000472
In short: On September 19, 2019, FDA issued a Form 483 with 2 observations to AstraZeneca Nijmegen B.V. in Nijmegen, Netherlands (FEI 3003000472) after an inspection that ran Sep 12 – Sep 19, 2019. The investigator was Thuy T. Nguyen. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and production account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate deviation…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Thuy T. Nguyen
20 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmAstraZeneca Nijmegen B.V. history
The site's inspection history, in date order.
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 AstraZeneca Nijmegen B.V.?
FDA listed 2 observations on this Form 483, mostly about quality system and production. 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 AstraZeneca Nijmegen B.V.?
Thuy T. Nguyen is named on this Form 483, for the inspection of Sep 12 – Sep 19, 2019. Each investigator has a profile showing what they cite most.
When was AstraZeneca Nijmegen B.V. inspected by FDA?
The inspection ran Sep 12 – Sep 19, 2019, and the Form 483 is dated September 19, 2019.
How do I get the full Form 483 for AstraZeneca Nijmegen B.V.?
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.