1Aseptic processing and sterility assurance
Your firm states on the Microbiology Report that is issued to a client after sterility and/or fungal testing that the Test Method employed was USP <71>.
Inspection Record
ARL Biopharma, Inc. dba Analytical Research Laboratories — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Your firm states on the Microbiology Report that is issued to a client after endotoxin testing that the Test Method employed was USP <85>.
3Other quality system
Your firm has no documentation to show that all analytical methods used to test for potency (assay) have been validated for all drug products including drug products submitted for testing by NECC and Ameridose LLC.
4Other quality system
Your firm has had 13 confirmed endotoxin failures for various drug products from October 2010-October 2012.
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.
