1Aseptic processing and sterility assurance
Your firm uses a <Redacted B4> for the depyrogenation of glassware used in the production of sterile, injectable drug products.
Inspection Record
People’s Custom Rx and Clinical Care, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Your firm does not test all lots of intrathecal drug products for endotoxin prior to release.
3Equipment and facility
On 6/27/18, I observed that the magnahelic gauge monitoring differential pressure between the ISO 8 anteroom and unclassified area was at "O".
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.
