Ricola Ag
Form 483 issued February 18, 2022 · Laufen, Switzerland
- Inspection
- Feb 14 – Feb 18, 2022
- Investigator
- Matthew B. Casale
- Observations
- 1
- Pages
- 1
- FEI number
- 1000170866
In short: On February 18, 2022, FDA issued a Form 483 with 1 observation to Ricola Ag in Laufen, Switzerland (FEI 1000170866) after an inspection that ran Feb 14 – Feb 18, 2022. 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
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (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…
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 firmRicola Ag 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 Ricola Ag?
FDA listed 1 observation 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 Ricola Ag?
Matthew B. Casale is named on this Form 483, for the inspection of Feb 14 – Feb 18, 2022. Each investigator has a profile showing what they cite most.
When was Ricola Ag inspected by FDA?
The inspection ran Feb 14 – Feb 18, 2022, and the Form 483 is dated February 18, 2022.
How do I get the full Form 483 for Ricola Ag?
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.