Takeda Austria GmbH
Form 483 issued November 9, 2018 · Linz, Austria
- Investigator
- Ze Peng
- Observations
- 3
- Pages
- 5
- FEI number
- 3001157285
In short: On November 9, 2018, FDA issued a Form 483 with 3 observations to Takeda Austria GmbH in Linz, Austria (FEI 3001157285). The investigator was Ze Peng. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and facilities & equipment 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
Observation 1: scanned text, readable in the full document.
- 02
There are no extractables/leachables studies to support the use of the various OA) in the production…
- 03
Procedures established for Complaint Processing and Adverse Events are incomplete in that there is no definition…
This inspection in context
Ze Peng
2 documents · 2018–2019
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Austria.
The firmTakeda Austria GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Takeda Austria GmbH?
FDA listed 3 observations on this Form 483, mostly about materials, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Takeda Austria GmbH?
Ze Peng is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Takeda Austria GmbH inspected by FDA?
This Form 483 is dated November 9, 2018.
How do I get the full Form 483 for Takeda Austria GmbH?
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.