Venator Germany GmbH
Form 483 issued September 22, 2017 · Duisburg, Germany
- Inspection
- Sep 18 – Sep 22, 2017
- Investigator
- Djamila Harouaka
- Observations
- 7
- Pages
- 5
- FEI number
- 1000180094
In short: On September 22, 2017, FDA issued a Form 483 with 7 observations to Venator Germany GmbH in Duisburg, Nordrhein-Westfalen (FEI 1000180094) after an inspection that ran Sep 18 – Sep 22, 2017. The investigator was Djamila Harouaka. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 5 of 7 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There was a failure to establish an ongoing stability program…
- 02
Sampling plans for finished active pharmaceutical ingredients are not supported by scientific…
- 03
The ranges of process parameters listed in the Master Batch Record are not clearly defined. pe…
- 04
Critical steps in the production batch record are not checked and signed by a…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmVenator Germany GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Venator Germany GmbH?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Venator Germany GmbH?
Djamila Harouaka is named on this Form 483, for the inspection of Sep 18 – Sep 22, 2017. Each investigator has a profile showing what they cite most.
When was Venator Germany GmbH inspected by FDA?
The inspection ran Sep 18 – Sep 22, 2017, and the Form 483 is dated September 22, 2017.
How do I get the full Form 483 for Venator Germany 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.