Inspection Record

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceuticals — FDA 483 Findings

US FDAInspected 2019-12-20Published 2020-03-09 7 findingsDeviation, CAPA, and investigationTraining and personnelEquipment and facilityAseptic processing and sterility assuranceQuality unit oversightDocumentation and records

Inspectors Erika V ButlerThe inspectors who signed the published document.Inspector lookup

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Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

2Training and personnel

Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices and written procedures required by current good manufacturing practice regulations.

3Equipment and facility

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.

4Aseptic processing and sterility assurance

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

5Aseptic processing and sterility assurance

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

6Quality unit oversight

The quality control unit lacks authority to fully investigate errors that have occurred.

7Documentation and records

Examination of packaging and labeling materials for suitability and correctness before packaging operations is not documented in the batch production records.

About this record

Extracted automatically from the document US FDA published on 2020-03-09. 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.

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceuticals company profile — full history US FDA documents, 2020 Go to Findings search