Similasan AG
Form 483 issued April 4, 2023 · Jonen, Switzerland
- Inspection
- Apr 3 – Apr 4, 2023
- Investigators
- Er Ol Freddy Ortiz-Colon· Lisa Shin· We Freddy Ortiz-Calon
- Observations
- 4
- Pages
- 4
- FEI number
- 1000110034
In short: On April 4, 2023, FDA issued a Form 483 with 4 observations to Similasan AG in Jonen, Switzerland (FEI 1000110034) after an inspection that ran Apr 3 – Apr 4, 2023. The investigators were Er Ol Freddy Ortiz-Colon, Lisa Shin and We Freddy Ortiz-Calon. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Specifically, For example: during the production of sterile product, during the production of sterile product, and/or…
- 03
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
- 04
The establishment of standards, test procedures and laboratory control mechanisms including any changes thereto, are not…
This inspection in context
Er Ol Freddy Ortiz-Colon
1 document · 2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Switzerland.
The firmSimilasan AG history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Similasan AG?
FDA listed 4 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Similasan AG?
Er Ol Freddy Ortiz-Colon, Lisa Shin and We Freddy Ortiz-Calon are named on this Form 483, for the inspection of Apr 3 – Apr 4, 2023. Each investigator has a profile showing what they cite most.
When was Similasan AG inspected by FDA?
The inspection ran Apr 3 – Apr 4, 2023, and the Form 483 is dated April 4, 2023.
How do I get the full Form 483 for Similasan 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.