Takeda Manufacturing Austria AG
Form 483 issued June 24, 2022 · WIEN, Austria
- Inspection
- Jun 13 – Jun 24, 2022
- Investigators
- Mikhail Ovanesov· Prabhu P. Raju· Travis S. Bradley
- Observations
- 3
- Pages
- 5
- FEI number
- 3002807133
In short: On June 24, 2022, FDA issued a Form 483 with 3 observations to Takeda Manufacturing Austria AG in WIEN, Austria (FEI 3002807133) after an inspection that ran Jun 13 – Jun 24, 2022. The investigators were Mikhail Ovanesov, Prabhu P. Raju and Travis S. Bradley. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Quality system and production account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies, the failure of a batch or any of its…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to…
- 03
Written procedures for sampling and testing plans are not followed…
This inspection in context
Mikhail Ovanesov
4 documents · 2016–2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Austria.
The firmTakeda Manufacturing Austria AG 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 Takeda Manufacturing Austria AG?
FDA listed 3 observations on this Form 483, mostly about quality system, production and laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Takeda Manufacturing Austria AG?
Mikhail Ovanesov, Prabhu P. Raju and Travis S. Bradley are named on this Form 483, for the inspection of Jun 13 – Jun 24, 2022. Each investigator has a profile showing what they cite most.
When was Takeda Manufacturing Austria AG inspected by FDA?
The inspection ran Jun 13 – Jun 24, 2022, and the Form 483 is dated June 24, 2022.
How do I get the full Form 483 for Takeda Manufacturing Austria AG?
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.