Form 483 · FEI 3013358387
Form 483 issued February 9, 2024 · Ljubljana, Slovenia
- Inspection
- Jan 29 – Feb 9, 2024
- Investigators
- Bijoy Panicker· Haitao Li
- Observations
- 3
- Pages
- 2
- FEI number
- 3013358387
In short: On February 9, 2024, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Ljubljana, Slovenia (FEI 3013358387) after an inspection that ran Jan 29 – Feb 9, 2024. The investigators were Bijoy Panicker and Haitao Li. Most observations concern facilities & equipment and laboratory controls.
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine calibration and checking of automatic and mechanical equipment is not performed according to a written…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
This inspection in context
Bijoy Panicker
34 documents · 2017–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Bijoy Panicker and Haitao Li are named on this Form 483, for the inspection of Jan 29 – Feb 9, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jan 29 – Feb 9, 2024, and the Form 483 is dated February 9, 2024.
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.