UCB Farchim SA
Form 483 issued July 4, 2023 · Bulle, Switzerland
- Inspection
- Jun 26 – Jul 4, 2023
- Investigator
- Arsen Karapetyan
- Observations
- 4
- Pages
- 4
- FEI number
- 3005023799
In short: On July 4, 2023, FDA issued a Form 483 with 4 observations to UCB Farchim SA in Bulle, Fribourg (FEI 3005023799) after an inspection that ran Jun 26 – Jul 4, 2023. The investigator was Arsen Karapetyan. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Quality unit oversight over quality control operations is deficient, including laboratory and productions electronic systems and…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in laboratory…
- 03
The accuracy, sensitivity, specificity, and reproducibility of test methods have not…
- 04
Written procedures are lacking which describe in suffic ient detail…
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 firmUCB Farchim SA 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 UCB Farchim SA?
FDA listed 4 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected UCB Farchim SA?
Arsen Karapetyan is named on this Form 483, for the inspection of Jun 26 – Jul 4, 2023. Each investigator has a profile showing what they cite most.
When was UCB Farchim SA inspected by FDA?
The inspection ran Jun 26 – Jul 4, 2023, and the Form 483 is dated July 4, 2023.
How do I get the full Form 483 for UCB Farchim SA?
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.