IOI Oleo GmbH
Form 483 issued January 17, 2020 · Witten, Germany
- Inspection
- Jan 13 – Jan 17, 2020
- Investigator
- Junho Pak
- Observations
- 4
- Pages
- 3
- FEI number
- 3002807213
In short: On January 17, 2020, FDA issued a Form 483 with 4 observations to IOI Oleo GmbH in Witten, Germany (FEI 3002807213) after an inspection that ran Jan 13 – Jan 17, 2020. The investigator was Junho Pak. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint records are deficient in that they do not include the findings of the…
- 02
Routine calibration of automatic, mechanical and electronic equipment is not performed according to a written program…
- 03
Each lot of drug product containers and closures was not appropriately identified as to its status…
- 04
Employees are not given training in the particular operations they perform as part of their function…
This inspection in context
Junho Pak
28 documents · 2012–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmIOI Oleo GmbH 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 IOI Oleo GmbH?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected IOI Oleo GmbH?
Junho Pak is named on this Form 483, for the inspection of Jan 13 – Jan 17, 2020. Each investigator has a profile showing what they cite most.
When was IOI Oleo GmbH inspected by FDA?
The inspection ran Jan 13 – Jan 17, 2020, and the Form 483 is dated January 17, 2020.
How do I get the full Form 483 for IOI Oleo GmbH?
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.