1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Providence Health and Services Washington Dba Providence Infusion Hospital Services — FDA 483 Findings
Inspectors Nathaniel B Phillips Sylvain · Kenneth O GeeThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen~free is not laboratory tested to determine conformance to such requirements.
3Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
4Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.
About this record
Extracted automatically from the document US FDA published on 2021-12-17. 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.
