Pajunk GmbH
Form 483 issued February 18, 2016 · Geisingen, Germany
- Inspection
- Feb 15 – Feb 18, 2016
- Investigator
- Jacqueline S. Warner
- Observations
- 3
- Pages
- 3
- FEI number
- 3002807847
In short: On February 18, 2016, FDA issued a Form 483 with 3 observations to Pajunk GmbH in Geisingen, Germany (FEI 3002807847) after an inspection that ran Feb 15 – Feb 18, 2016. The investigator was Jacqueline S. Warner. Most observations concern production & process controls and design controls.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design input have…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
- 03
Purchasing data that clearly describe or reference specified requirements for purchased or otherwise received product and…
This inspection in context
Jacqueline S. Warner
7 documents · 2008–2024
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in New York.
The firmPajunk GmbH history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Pajunk GmbH?
FDA listed 3 observations on this Form 483, mostly about production & process controls and design controls. The opening words of each observation are shown on this page.
Who inspected Pajunk GmbH?
Jacqueline S. Warner is named on this Form 483, for the inspection of Feb 15 – Feb 18, 2016. Each investigator has a profile showing what they cite most.
When was Pajunk GmbH inspected by FDA?
The inspection ran Feb 15 – Feb 18, 2016, and the Form 483 is dated February 18, 2016.
How do I get the full Form 483 for Pajunk 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.