Evonik Corporation
Form 483 issued January 10, 2020 · Birmingham, Alabama
- Investigator
- Claire M. Minden
- Observations
- 7
- Pages
- 3
- FEI number
- 3012757951
In short: On January 10, 2020, FDA issued a Form 483 with 7 observations to Evonik Corporation in Birmingham, Alabama (FEI 3012757951). The investigator was Claire M. Minden. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
Most cited: 21 CFR 211.68 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Input to and output from the computer and records or data are not checked for accuracy…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmEvonik Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Evonik Corporation?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Evonik Corporation?
Claire M. Minden is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Evonik Corporation inspected by FDA?
This Form 483 is dated January 10, 2020.
How do I get the full Form 483 for Evonik Corporation?
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.