Evonik Corporation
Form 483 issued December 10, 2024 · Birmingham, Alabama
- Inspection
- Dec 3 – Dec 10, 2024
- Investigator
- Camerson E. Moore
- Observations
- 6
- Pages
- 5
- FEI number
- 3012757951
In short: On December 10, 2024, FDA issued a Form 483 with 6 observations to Evonik Corporation in Birmingham, Alabama (FEI 3012757951) after an inspection that ran Dec 3 – Dec 10, 2024. The investigator was Camerson E. Moore. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
- 03
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
- 04
Routine calibration, inspection and checking of mechanical equipment is not performed according to a written program…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.28
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Evonik Corporation?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected Evonik Corporation?
Camerson E. Moore is named on this Form 483, for the inspection of Dec 3 – Dec 10, 2024. Each investigator has a profile showing what they cite most.
When was Evonik Corporation inspected by FDA?
The inspection ran Dec 3 – Dec 10, 2024, and the Form 483 is dated December 10, 2024.
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.