Alvotech Hf — FDA 483 Findings

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

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

There is a lack of assurance that your drug substance and drug product manufacturing operations are appropriately designed to ensure the prevention of contamination of equipment or product by environmental and processing conditions that would be expected to have an adverse effect on product quality.

Materials management is deficient.

Your firm's documentation practices are deficient.

Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure that components and in-process materials conform to appropriate standards of identity, strength, quality, and purity.

Written records of unexplained discrepancies or the failure of a batch or any of its components to meet specification, do not always contain a thorough investigation, or appropriate documentation, conclusions, and follow-up.

Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Your firm failed to exercise appropriate controls to protect the electronic data acquisition and process control systems used for OS and DP manufacturing and testing.

Your quality unit does not fully exercise its responsibilities regarding service contractor qualification.