Form 483 · FEI 1000282452
Form 483 issued March 24, 2017 · Opava, Czech Republic
- Inspection
- Mar 20 – Mar 24, 2017
- Investigators
- Christina A. Miller· Laurimer Kuilan-Torres
- Observations
- 1
- Pages
- 1
- FEI number
- 1000282452
In short: On March 24, 2017, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Opava, Czech Republic (FEI 1000282452) after an inspection that ran Mar 20 – Mar 24, 2017. The investigators were Christina A. Miller and Laurimer Kuilan-Torres. 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
Procedures describing the handling of written and oral complaints related to drug products are…
This inspection in context
Christina A. Miller
10 documents · 2010–2017
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmSite 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 an FDA-inspected site?
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 an FDA-inspected site?
Christina A. Miller and Laurimer Kuilan-Torres are named on this Form 483, for the inspection of Mar 20 – Mar 24, 2017. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Mar 20 – Mar 24, 2017, and the Form 483 is dated March 24, 2017.
How do I get the full Form 483 for an FDA-inspected site?
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.