Inspection Record

MPRX, Inc. dba Medical Park Pharmacy — FDA 483 Findings

US FDAInspected 2019-11-22Published 2020-01-07 4 findingsEquipment and facilityOther quality systemContamination control

Inspectors Claire M. MindenThe 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

Vermin was observed in your production area.

2Other quality system

Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

3Equipment and facility

Calibration of mechanical equipment is not performed daily or an a routine schedule designed to assure proper performance.

4Contamination control

You produced highly potent drugs without providing adequate to prevent cross-contamination.

About this record

Extracted automatically from the document US FDA published on 2020-01-07. 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.

MPRX, Inc. dba Medical Park Pharmacy company profile — full history US FDA documents, 2020 Go to Findings search