DOTTIKON EXCLUSIVE SYNTHESIS AG
Form 483 issued December 16, 2022 · Dottikon, Switzerland
- Investigator
- Nicole E. Knowlton
- Observations
- 1
- Pages
- 2
- FEI number
- 3002806909
In short: On December 16, 2022, FDA issued a Form 483 with 1 observation to DOTTIKON EXCLUSIVE SYNTHESIS AG in Dottikon, Aargau (FEI 3002806909). The investigator was Nicole E. Knowlton. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmDOTTIKON EXCLUSIVE SYNTHESIS AG history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DOTTIKON EXCLUSIVE SYNTHESIS AG?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected DOTTIKON EXCLUSIVE SYNTHESIS AG?
Nicole E. Knowlton is named on this Form 483. Each investigator has a profile showing what they cite most.
When was DOTTIKON EXCLUSIVE SYNTHESIS AG inspected by FDA?
This Form 483 is dated December 16, 2022.
How do I get the full Form 483 for DOTTIKON EXCLUSIVE SYNTHESIS AG?
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.