MeK.o Laser Material Processing

FDA inspection history across 2 sites, 2016

2
Form 483s

Every document, by year

  • Form 483

2016: two Form 483s.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2016Two Form 483s, at Sarstedt, Germany and SARSTEDT, Germany.
  2. 2016The longest 483 on file: 2 observations over 3 pages at SARSTEDT, Germany.

Cited most

Across all MeK.o Laser Material Processing observations on file

The complete MeK.o Laser Material Processing file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2016-12-19483 Form 483$99
2016-02-11483 Form 483$99

Investigators on these documents

Jacqueline S. Warner (1)

FEI number 3009937642 · most recent document Dec 19, 2016

About MeK.o Laser Material Processing

How many FDA Form 483s has MeK.o Laser Material Processing received?

FDA Intel has 2 Form 483s on file for MeK.o Laser Material Processing; the most recent is dated Dec 19, 2016.

When was MeK.o Laser Material Processing last inspected by FDA?

The most recent FDA inspection document on file for MeK.o Laser Material Processing is a Form 483 dated Dec 19, 2016, for the site in Sarstedt, Germany.

What did FDA cite at MeK.o Laser Material Processing?

The regulations cited most in the observations on file for MeK.o Laser Material Processing are 21 CFR 820.75 (Process validation), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time.