Cambrex Karlskoga AB
Form 483 issued May 27, 2016 · Karlskoga, Sweden
- Inspection
- May 23 – May 27, 2016
- Investigator
- Nicholas L. Paulin
- Observations
- 1
- Pages
- 1
- FEI number
- 3001686607
In short: On May 27, 2016, FDA issued a Form 483 with 1 observation to Cambrex Karlskoga AB in Karlskoga, Sweden (FEI 3001686607) after an inspection that ran May 23 – May 27, 2016. The investigator was Nicholas L. Paulin. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your SOP 5533 titled, “Hantera kundreklamationer och produktreturer", (Revision 13), dated 2016-05-02 translated as "To Handle…
This inspection in context
Nicholas L. Paulin
7 documents · 2009–2018
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Ohio.
The firmCambrex Karlskoga AB history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cambrex Karlskoga AB?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Cambrex Karlskoga AB?
Nicholas L. Paulin is named on this Form 483, for the inspection of May 23 – May 27, 2016. Each investigator has a profile showing what they cite most.
When was Cambrex Karlskoga AB inspected by FDA?
The inspection ran May 23 – May 27, 2016, and the Form 483 is dated May 27, 2016.
How do I get the full Form 483 for Cambrex Karlskoga AB?
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.