Evonik Corporation
Form 483 issued August 10, 2018 · Birmingham, Alabama
- Inspection
- Jul 30 – Aug 10, 2018
- Observations
- 4
- Pages
- 4
- FEI number
- 3012757951
In short: On August 10, 2018, FDA issued a Form 483 with 4 observations to Evonik Corporation in Birmingham, Alabama (FEI 3012757951) after an inspection that ran Jul 30 – Aug 10, 2018. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Deviations from written production and process control…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions that would alter the…
This inspection in context
Questions about this 483
What did FDA find at Evonik Corporation?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
When was Evonik Corporation inspected by FDA?
The inspection ran Jul 30 – Aug 10, 2018, and the Form 483 is dated August 10, 2018.
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.