Inspection Record

Alvotech Hf — FDA 483 Findings

US FDAInspected 2026-05-08Published 2026-07-15 4 findingsLaboratory and QC controlsComplaint and recall handlingQuality unit oversightAseptic processing and sterility assurance

View the regulator's official source The source document is always the basis for judgement.

Findings

1Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity.

2Complaint and recall handling

Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.

3Quality unit oversight

The responsibilities and procedures applicable to the quality unit are not fully followed.

4Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

About this record

Extracted automatically from the document US FDA published on 2026-07-15. 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.

Other records for this company

2025-07-04 · US FDA · 10 findings2023-03-17 · US FDA · 7 findings
Alvotech Hf company profile — full history US FDA documents, 2026 Go to Findings search