MeK.o Laser Material Processing
Form 483 issued December 19, 2016 · Sarstedt, Germany
- Inspection
- Dec 12 – Dec 19, 2016
- Observations
- 1
- Pages
- 1
- FEI number
- 3009937642
In short: On December 19, 2016, FDA issued a Form 483 with 1 observation to MeK.o Laser Material Processing in Sarstedt, Germany (FEI 3009937642) after an inspection that ran Dec 12 – Dec 19, 2016. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.75 (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 actmties did not include Performance Qualification (PQ) activities for W related with the manufacturing…
This inspection in context
Questions about this 483
What did FDA find at MeK.o Laser Material Processing?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
When was MeK.o Laser Material Processing inspected by FDA?
The inspection ran Dec 12 – Dec 19, 2016, and the Form 483 is dated December 19, 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.