Lyocontract GmbH
Form 483 issued September 20, 2019 · Ilsenburg, Germany
- Inspection
- Sep 16 – Sep 20, 2019
- Investigator
- Zachary L. Stamm
- Observations
- 3
- Pages
- 2
- FEI number
- 3014034890
In short: On September 20, 2019, FDA issued a Form 483 with 3 observations to Lyocontract GmbH in Ilsenburg, Germany (FEI 3014034890) after an inspection that ran Sep 16 – Sep 20, 2019. The investigator was Zachary L. Stamm. Most observations concern laboratory controls.
At a glance
3 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 02
Established test procedures and laboratory control mechanisms are not documented at the…
- 03
Laboratory records do not include complete records of any testing and standardization…
This inspection in context
Zachary L. Stamm
13 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Colorado.
The firmLyocontract GmbH history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lyocontract GmbH?
FDA listed 3 observations on this Form 483, mostly about laboratory controls. The opening words of each observation are shown on this page.
Who inspected Lyocontract GmbH?
Zachary L. Stamm is named on this Form 483, for the inspection of Sep 16 – Sep 20, 2019. Each investigator has a profile showing what they cite most.
When was Lyocontract GmbH inspected by FDA?
The inspection ran Sep 16 – Sep 20, 2019, and the Form 483 is dated September 20, 2019.
How do I get the full Form 483 for Lyocontract 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.