C.A.T. Gmbh and Co. KG Heerweg 10
Form 483 issued March 20, 2012 · Tubingen, Germany
- Inspection
- Mar 16 – Mar 20, 2012
- Investigator
- Elizabeth L. Edwards
- Observations
- 1
- Pages
- 1
- FEI number
- 3004422881
In short: On March 20, 2012, FDA issued a Form 483 with 1 observation to C.A.T. Gmbh and Co. KG Heerweg 10 in Tubingen, Germany (FEI 3004422881) after an inspection that ran Mar 16 – Mar 20, 2012. The investigator was Elizabeth L. Edwards. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The establishment of test procedures and laboratory control mechanisms including any changes thereto, are not drafted…
This inspection in context
Elizabeth L. Edwards
2 documents · 2012–2015
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmC.A.T. Gmbh and Co. KG Heerweg 10 history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at C.A.T. Gmbh and Co. KG Heerweg 10?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected C.A.T. Gmbh and Co. KG Heerweg 10?
Elizabeth L. Edwards is named on this Form 483, for the inspection of Mar 16 – Mar 20, 2012. Each investigator has a profile showing what they cite most.
When was C.A.T. Gmbh and Co. KG Heerweg 10 inspected by FDA?
The inspection ran Mar 16 – Mar 20, 2012, and the Form 483 is dated March 20, 2012.
How do I get the full Form 483 for C.A.T. Gmbh and Co. KG Heerweg 10?
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