1Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment used in the manufacturing, processing, or holding of a drug product.
Inspection Record
Wacker Biotech B.V. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
3Data integrity
Input to and output from the electronic records and data are not checked for accuracy.
4Laboratory and QC controls
Laboratory testing procedures lack sufficient testing requirements to ensure accurate and scientifically sound determination of the test materials.
5Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
About this record
Extracted automatically from the document US FDA published on 2026-07-27. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
