MeK.o Laser Material Processing
Form 483 issued February 11, 2016 · SARSTEDT, Germany
- Inspection
- Feb 8 – Feb 11, 2016
- Investigator
- Jacqueline S. Warner
- Observations
- 2
- Pages
- 3
- FEI number
- 3009937642
In short: On February 11, 2016, FDA issued a Form 483 with 2 observations to MeK.o Laser Material Processing in SARSTEDT, Germany (FEI 3009937642) after an inspection that ran Feb 8 – Feb 11, 2016. The investigator was Jacqueline S. Warner. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.75 (1×) · 820.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation activities and results have not been documented, approved…
- 02
Procedures have not been adequately established to control product that does not…
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 firmMeK.o Laser Material Processing history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MeK.o Laser Material Processing?
FDA listed 2 observations on this Form 483, mostly about production & process controls and cAPA. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected MeK.o Laser Material Processing?
Jacqueline S. Warner is named on this Form 483, for the inspection of Feb 8 – Feb 11, 2016. Each investigator has a profile showing what they cite most.
When was MeK.o Laser Material Processing inspected by FDA?
The inspection ran Feb 8 – Feb 11, 2016, and the Form 483 is dated February 11, 2016.
How do I get the full Form 483 for MeK.o Laser Material Processing?
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.