Inspection Record

InfuScience a subsidiary of Bioscrip — FDA 483 Findings

US FDAInspected 2015-07-17Published 2024-01-17 10 findingsEquipment and facilityStability and storageLaboratory and QC controlsComplaint and recall handlingTraining and personnelAseptic processing and sterility assuranceContamination control

Inspectors Viviana Matta · Carmen Y. KellyThe inspectors who signed the published document.Inspector lookup

View the regulator's official source The source document is always the basis for judgement.

Findings

1Equipment and facility

Buildings used in the holding of a drug product are not maintained in a good state of repair.

2Stability and storage

There is no written testing program designed to assess the stability characteristics of drug products.

3Laboratory and QC controls

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory confom1ance to the final specifications prior to release.

4Complaint and recall handling

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

5Training and personnel

Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.

6Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

7Aseptic processing and sterility assurance

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

8Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.

9Contamination control

The separate or defined areas necessary to prevent contamination or mix-ups are deficient.

10Aseptic processing and sterility assurance

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce asepti c conditions.

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.

InfuScience a subsidiary of Bioscrip company profile — full history US FDA documents, 2024 Go to Findings search