Wacker Biotech B.V. Paalbergweg 2
Form 483 issued November 21, 2025 · Amsterdam, Netherlands
- Inspection
- Nov 17 – Nov 21, 2025
- Observations
- 5
- Pages
- 4
- FEI number
- 3008539577
In short: On November 21, 2025, FDA issued a Form 483 with 5 observations to Wacker Biotech B.V. Paalbergweg 2 in Amsterdam, Netherlands (FEI 3008539577) after an inspection that ran Nov 17 – Nov 21, 2025. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Input to and output from the electronic records and data are…
- 03
Laboratory testing procedures lack sufficient testing requirements to ensure accurate and scientifically sound determination…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Questions about this 483
What did FDA find at Wacker Biotech B.V. Paalbergweg 2?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and production. The opening words of each observation are shown on this page.
When was Wacker Biotech B.V. Paalbergweg 2 inspected by FDA?
The inspection ran Nov 17 – Nov 21, 2025, and the Form 483 is dated November 21, 2025.
How do I get the full Form 483 for Wacker Biotech B.V. Paalbergweg 2?
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.