1Aseptic processing and sterility assurance
The <Redacted B4> used for depyrogenation of product/equipment intended to be sterile were not lethal to heat-resistant microorganisms.
Inspection Record
Revive Rx, LLC dba Revive Rx Pharmacy — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Validation and qualification
The certification of the ISO 5 areas was inadequate.
3Aseptic processing and sterility assurance
Product intended to be sterile was exposed to lower than ISO 5 classified quality air.
4Aseptic processing and sterility assurance
Media fills are not performed that closely simulate aseptic production operations, incorporating, as appropriate, worst case activities and conditions that provide a challenge to aseptic operalions.
5Material and supplier control
Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.
About this record
Extracted automatically from the document US FDA published on 2021-10-28. 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.
