1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
Alvotech Hf — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in quality control records are instituted only by authorized personnel.
3Aseptic processing and sterility assurance
OATE(SI OF INSl'ECTION 03/06/2023-03/17/2023 FEINUMBER 3013702557 Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
4Other quality system
lDn4J---~ Quality ofincoming stoppers is inadequate.
5Equipment and facility
Equipment used in testing and holding operations in support of drug substances and drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.
6Quality unit oversight
The responsibilities and procedures applicable to the quality unit are not in writing and fully followed.
7Validation and qualification
Container closure integrity assay validation is inadequate.
About this record
Extracted automatically from the document US FDA published on 2023-04-26. 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.
