Merck Kommanditgesellschaft auf Aktien
Form 483 issued July 2, 2009 · Darmstadt, Germany
- Inspection
- Jun 29 – Jul 2, 2009
- Investigator
- Evelyn Taha
- Observations
- 3
- Pages
- 252
- FEI number
- 3002806906
In short: On July 2, 2009, FDA issued a Form 483 with 3 observations to Merck Kommanditgesellschaft auf Aktien in Darmstadt, Germany (FEI 3002806906) after an inspection that ran Jun 29 – Jul 2, 2009. The investigator was Evelyn Taha. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures were not followed for the control of products that do…
- 02
Employee training is not…
- 03
Required records are not…
This inspection in context
Evelyn Taha
2 documents · 1996–2009
Cites 820.180 (general requirements) more than any other section. Most of their documents are for sites in Germany.
The firmMerck Kommanditgesellschaft auf Aktien history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck Kommanditgesellschaft auf Aktien?
FDA listed 3 observations on this Form 483, mostly about cAPA, management controls and records & documents. The opening words of each observation are shown on this page.
Who inspected Merck Kommanditgesellschaft auf Aktien?
Evelyn Taha is named on this Form 483, for the inspection of Jun 29 – Jul 2, 2009. Each investigator has a profile showing what they cite most.
When was Merck Kommanditgesellschaft auf Aktien inspected by FDA?
The inspection ran Jun 29 – Jul 2, 2009, and the Form 483 is dated July 2, 2009.
How do I get the full Form 483 for Merck Kommanditgesellschaft auf Aktien?
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.