Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany
Form 483 issued June 20, 2025 · Dreieich, Germany
- Inspection
- Jun 12 – Jun 20, 2025
- Investigators
- Hoda Thai· Prajakta Varadkar· Sergey Akimov
- Observations
- 8
- Pages
- 6
- FEI number
- 3001034985
In short: On June 20, 2025, FDA issued a Form 483 with 8 observations to Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany in Dreieich, Germany (FEI 3001034985) after an inspection that ran Jun 12 – Jun 20, 2025. The investigators were Hoda Thai, Prajakta Varadkar and Sergey Akimov. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.100 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Aseptic control and cleanliness…
- 04
Procedures are not established to…
This inspection in context
Hoda Thai
1 document · 2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
The firmBiotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany?
FDA listed 8 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany?
Hoda Thai, Prajakta Varadkar and Sergey Akimov are named on this Form 483, for the inspection of Jun 12 – Jun 20, 2025. Each investigator has a profile showing what they cite most.
When was Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany inspected by FDA?
The inspection ran Jun 12 – Jun 20, 2025, and the Form 483 is dated June 20, 2025.
How do I get the full Form 483 for Biotest AG, Germany ! {.andsteinerstrahe 5, 63303 Dreieich. Germany?
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.