A/S Orthana Kemisk Fabrik
Form 483 issued September 23, 2022 · Kastrup, Denmark
- Inspection
- Sep 19 – Sep 23, 2022
- Investigator
- Adetutu Gidado
- Observations
- 5
- Pages
- 2
- FEI number
- 1000248695
In short: On September 23, 2022, FDA issued a Form 483 with 5 observations to A/S Orthana Kemisk Fabrik in Kastrup, Hovedstaden (FEI 1000248695) after an inspection that ran Sep 19 – Sep 23, 2022. The investigator was Adetutu Gidado. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Quality system and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibility of the Quality Unit…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
The firmA/S Orthana Kemisk Fabrik history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at A/S Orthana Kemisk Fabrik?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected A/S Orthana Kemisk Fabrik?
Adetutu Gidado is named on this Form 483, for the inspection of Sep 19 – Sep 23, 2022. Each investigator has a profile showing what they cite most.
When was A/S Orthana Kemisk Fabrik inspected by FDA?
The inspection ran Sep 19 – Sep 23, 2022, and the Form 483 is dated September 23, 2022.
How do I get the full Form 483 for A/S Orthana Kemisk Fabrik?
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