1Aseptic processing and sterility assurance
<Redacted B4> is not sterilized by routine sterilization cycles and cleaning process of the <Reda cted B4> is inadequate.
Inspection Record
Innoveix Pharmaceuticals Inc — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
You firm uses a non-pharmaceutical grade detergent to clean and sanitize glassware used in the production of your compounded sterile <Redacted B4> injectable drug products.
3Aseptic processing and sterility assurance
The cycle parameters (temperature, pressure and time) used for <Re dact ed B4> of product intended t o be sterile were not lethal to heat-resistant microorganisms.
4Aseptic processing and sterility assurance
The <Redac ted B4> intended to render final product sterile was not pharmaceutical grade.
5Aseptic processing and sterility assurance
Disinfecting agents used in the ISO5 classified aseptic processing areas were not sterile.
6Aseptic processing and sterility assurance
Method suitability has not been conducted on your sterile drug products that are sent for sterility testing.
7Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations in an area that blocked movement of first pass air around an open unit, either before or after it was filled with sterile produc t.
8Aseptic processing and sterility assurance
Failure to conduct media fills that closely simulates aseptic production operations under the worst case, most challenging and stressful conditions.
About this record
Extracted automatically from the document US FDA published on 2021-10-20. 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.
