Teva Biotech GmbH
Form 483 issued March 21, 2025 · Ulm, Germany
- Inspection
- Mar 13 – Mar 21, 2025
- Investigators
- Wayne Seifert· Ying-Xin Fan
- Observations
- 7
- Pages
- 5
- FEI number
- 3007817154
In short: On March 21, 2025, FDA issued a Form 483 with 7 observations to Teva Biotech GmbH in Ulm, Germany (FEI 3007817154) after an inspection that ran Mar 13 – Mar 21, 2025. The investigators were Wayne Seifert and Ying-Xin Fan. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You failed to adequately conduct process validation in the documented evidence that your manufacturing process operates…
- 02
A building and facility used in the manufacture of ns substance is not designed to facilitate…
- 03
Laboratory control over test…
- 04
You fail to exercise appropriate controls over computer systems…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
The firmTeva Biotech GmbH 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 Teva Biotech GmbH?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. 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 Teva Biotech GmbH?
Wayne Seifert and Ying-Xin Fan are named on this Form 483, for the inspection of Mar 13 – Mar 21, 2025. Each investigator has a profile showing what they cite most.
When was Teva Biotech GmbH inspected by FDA?
The inspection ran Mar 13 – Mar 21, 2025, and the Form 483 is dated March 21, 2025.
How do I get the full Form 483 for Teva Biotech GmbH?
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.