Takeda GmbH
Form 483 issued March 16, 2018 · Oranienburg, Germany
- Inspection
- Mar 12 – Mar 16, 2018
- Investigator
- Kenneth E. Felkley
- Observations
- 1
- Pages
- 1
- FEI number
- 3002807809
In short: On March 16, 2018, FDA issued a Form 483 with 1 observation to Takeda GmbH in Oranienburg, Brandenburg (FEI 3002807809) after an inspection that ran Mar 12 – Mar 16, 2018. The investigator was Kenneth E. Felkley. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations of an unexplained discrepancy did not extend to other batches of…
This inspection in context
Kenneth E. Felkley
3 documents · 2016–2018
Cites 117.20 (plant and grounds) more than any other section. Most of their documents are for sites in Germany.
The firmTakeda GmbH 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 GmbH?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 Takeda GmbH?
Kenneth E. Felkley is named on this Form 483, for the inspection of Mar 12 – Mar 16, 2018. Each investigator has a profile showing what they cite most.
When was Takeda GmbH inspected by FDA?
The inspection ran Mar 12 – Mar 16, 2018, and the Form 483 is dated March 16, 2018.
How do I get the full Form 483 for Takeda 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.