Inspection Record

EHT Pharmacy LLC dba Curexa — FDA 483 Findings

US FDAInspected 2020-10-10Published 2020-12-22 3 findingsContamination controlLaboratory and QC controlsEquipment and facility

Inspectors Nancy M Espinal · William J MuszynskiThe inspectors who signed the published document.Inspector lookup

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

Findings

1Contamination control

Non-microbial contamination was observed in your production area.

2Laboratory and QC controls

Laboratory analysis of hormone sample determined the strength was below the declared label claim.

3Equipment and facility

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

About this record

Extracted automatically from the document US FDA published on 2020-12-22. 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.

EHT Pharmacy LLC dba Curexa company profile — full history US FDA documents, 2020 Go to Findings search