1Laboratory 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.
Inspection Record
Siegfried Pharma AG — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
3Deviation, CAPA, and investigation
Written procedures are not followed for evaluations done at least annually and including provisions for a review of investigations conducted for each drug product.
4Laboratory and QC controls
Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
5Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
About this record
Extracted automatically from the document US FDA published on 2026-07-13. 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.
