1Aseptic processing and sterility assurance
Pressure differentials between areas with different air classifications were not monitored prior or during sterile drug production.
Inspection Record
Life Science Pharmacy Inc — FDA 483 Findings
Inspectors Rachael A MoliverThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Validation and qualification
ISO-5 classified areas were not certified under dynamic conditions.
3Environmental monitoring
The use of sporicidal agents in the cleanrooms and/or ISO 5 area is inadequate or infrequent.
4Material and supplier control
Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.
5Aseptic processing and sterility assurance
Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations.
About this record
Extracted automatically from the document US FDA published on 2021-07-07. 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.
