Bioiberica SAU
Form 483 issued February 4, 2022 · Palafolls, Spain
- Inspection
- Feb 4, 2022
- Investigator
- Arsen Karapetyan
- Observations
- 5
- Pages
- 5
- FEI number
- 1000418405
In short: On February 4, 2022, FDA issued a Form 483 with 5 observations to Bioiberica SAU in Palafolls, Barcelona (FEI 1000418405) after an inspection that ran Feb 4, 2022. The investigator was Arsen Karapetyan. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 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
Cleaning procedures for equipment used in the campaign manufacture of drug substances are not validated to…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
The quality control unit lacks responsibility to approve all procedures or specifications impacting on identity, strength…
- 04
There is no written testing program designed to assess the stab ility…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Bioiberica SAU?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Bioiberica SAU?
Arsen Karapetyan is named on this Form 483, for the inspection of Feb 4, 2022. Each investigator has a profile showing what they cite most.
When was Bioiberica SAU inspected by FDA?
The inspection ran Feb 4, 2022, and the Form 483 is dated February 4, 2022.
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.