1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.
Inspection Record
Vann Healthcare — FDA 483 Findings
Inspectors Michael P. SheehanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced.
3Contamination control
The control systems necessary to prevent contamination or mix-ups are deficient.
4Material and supplier control
Rejected components are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
