1Equipment and facility
On 6/27/18, I observed that the magnahelic gauge monitoring differential pressure between the ISO 8 anteroom
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
2Aseptic processing and sterility assurance
Your firm uses a <Redacted B4> for the depyrogenation of glassware in the production of sterile, injectable drug products.
3Other quality system
You have no assurance that the endotoxin level ofyour intrathecal drug products are safe, since you do not have any endotoxin data and your firm doesn't perform endotoxin testing for the finished product.
4Other quality system
SOP #3.300.303 entitle, "Disinfectant Solution and <Re dacted B4>' (Effective date: 9/1/17) does not id entify the contact time used for th e < Redact ed B 4> and <Redacted B4> disinfectants.
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.
