1Aseptic processing and sterility assurance
Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.
Inspection Record
Auro Pharmacies — FDA 483 Findings
Inspectors Andrew K. HaackThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
JS0-5 classified areas were not certified under dynamic conditions.
3Material and supplier control
Each component is not tested for conformity with all appropriate written specifications fqr purity, strength, and quality.
4Equipment and facility
Buildings used in the manufacture, processing, packing, or holding o fa drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
5Equipment and facility
Vermin was observed in an area immediately adjacent to your production area.
6Aseptic processing and sterility assurance
You did not make adequate product evaluation and take remedial action where actionable microbial contamination was found to be present in the ISO 5 classified aseptic processing area during aseptic production.
7Stability and storage
The written stability testing program is not followed.
8Other quality system
You have not established appropriate Beyond Use Dates for your products.
9Aseptic 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 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.
