Similasan AG
FDA inspection history in Jonen, Switzerland, 2003 to 2023
- 3
- Warning letters
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2003: one warning letter; 2005: one warning letter; 2023: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2003–05Two warning letters, at Jonen, Switzerland.
- 2023One warning letter and one Form 483, at Jonen, Switzerland.
Cited most
Across all Similasan AG observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Similasan AG file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Jonen, Switzerland
Two warning letters, one Form 483 and one close-out letter · 2005 to 2023 · 4 observations
Latest: Warning letter, Sep 11, 2023 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-11 | Warning letter Warning letter | Jonen, Switzerland | — | $99 |
| 2023-04-04 | 483 Form 483 | Jonen, Switzerland | 4 | $99 |
| 2005-08-16 | Warning letter Warning letter | Jonen, Switzerland | — | $99 |
| 2003-05-05 | Warning letter Warning letter | — | — | $99 |
| Undated | Close-out Close-out letter | Jonen, Switzerland | — | $99 |
Investigators on these documents
Er Ol Freddy Ortiz-Colon (1)Lisa Shin (1)We Freddy Ortiz-Calon (1)
FEI number 1000110034 · most recent document Sep 11, 2023
About Similasan AG
How many FDA Form 483s has Similasan AG received?
FDA Intel has 1 Form 483 on file for Similasan AG; the most recent is dated Apr 4, 2023.
When was Similasan AG last inspected by FDA?
The most recent FDA inspection document on file for Similasan AG is a Form 483 dated Apr 4, 2023, for the site in Jonen, Switzerland.
What did FDA cite at Similasan AG?
The regulations cited most in the observations on file for Similasan AG are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.
Has Similasan AG received an FDA warning letter?
Yes. FDA Intel has 3 FDA warning letters on file for Similasan AG; the most recent is dated Sep 11, 2023.