Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany
FDA inspection history in Dreieich, Germany, 2025
- 1
- Form 483
Every document, by year
- Form 483
2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2025One Form 483, at Dreieich, Germany.
Cited most
Across all Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.56Sanitation2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.160General requirements1
The complete Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Dreieich, Germany
One Form 483 · 2025 · 8 observations
Latest: Form 483, Jun 20, 2025 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-06-20 | 483 Form 483 | Dreieich, Germany | 8 | $99 |
Investigators on these documents
FEI number 3001034985 · most recent document Jun 20, 2025
About Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany
How many FDA Form 483s has Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany received?
FDA Intel has 1 Form 483 on file for Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany; the most recent is dated Jun 20, 2025.
When was Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany last inspected by FDA?
The most recent FDA inspection document on file for Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany is a Form 483 dated Jun 20, 2025, for the site in Dreieich, Germany.
What did FDA cite at Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany?
The regulations cited most in the observations on file for Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.56 (Sanitation), 2 times.