Corden Pharma Fribourg SA
Form 483 issued February 3, 2023 · Villars-sur-Glane, Switzerland
- Inspection
- Jan 30 – Feb 3, 2023
- Investigator
- Matthew B. Casale
- Observations
- 2
- Pages
- 2
- FEI number
- 3009018997
In short: On February 3, 2023, FDA issued a Form 483 with 2 observations to Corden Pharma Fribourg SA in Villars-sur-Glane, Switzerland (FEI 3009018997) after an inspection that ran Jan 30 – Feb 3, 2023. The investigator was Matthew B. Casale. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.180(e)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written procedures are not established and followed for evaluations done at least annually and including provisions…
This inspection in context
Matthew B. Casale
29 documents · 2015–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Ohio.
The firmCorden Pharma Fribourg SA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Corden Pharma Fribourg SA?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Corden Pharma Fribourg SA?
Matthew B. Casale is named on this Form 483, for the inspection of Jan 30 – Feb 3, 2023. Each investigator has a profile showing what they cite most.
When was Corden Pharma Fribourg SA inspected by FDA?
The inspection ran Jan 30 – Feb 3, 2023, and the Form 483 is dated February 3, 2023.
How do I get the full Form 483 for Corden Pharma Fribourg SA?
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