Inspection Record

Health Dimensions Inc. — FDA 483 Findings

US FDAInspected 2016-01-05Published 2024-01-17 5 findingsLaboratory and QC controlsComplaint and recall handlingOther quality systemAseptic processing and sterility assurance

Inspectors Jeffrey D. MengThe inspectors who signed the published document.Inspector lookup

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

Findings

1Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

2Complaint and recall handling

Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.

3Other quality system

Time lin1its are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

4Aseptic processing and sterility assurance

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

5Aseptic processing and sterility assurance

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

Health Dimensions Inc. company profile — full history US FDA documents, 2024 Go to Findings search