Bioiberica SAU
Form 483 issued September 20, 2024 · Palafolls, Spain
- Inspection
- Sep 13 – Sep 20, 2024
- Investigator
- Roger F. Zabinski
- Observations
- 2
- Pages
- 2
- FEI number
- 1000418405
In short: On September 20, 2024, FDA issued a Form 483 with 2 observations to Bioiberica SAU in Palafolls, Barcelona (FEI 1000418405) after an inspection that ran Sep 13 – Sep 20, 2024. The investigator was Roger F. Zabinski. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Laboratory controls do not include the establishment of scientifically sound…
This inspection in context
Roger F. Zabinski
36 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmBioiberica SAU history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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 Bioiberica SAU?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Bioiberica SAU?
Roger F. Zabinski is named on this Form 483, for the inspection of Sep 13 – Sep 20, 2024. Each investigator has a profile showing what they cite most.
When was Bioiberica SAU inspected by FDA?
The inspection ran Sep 13 – Sep 20, 2024, and the Form 483 is dated September 20, 2024.
How do I get the full Form 483 for Bioiberica SAU?
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.