Inspection Record

Healthy Choice Compounding LLC — FDA 483 Findings

US FDAInspected 2020-09-24Published 2020-12-22 3 findingsOther quality systemMaterial and supplier controlContamination control

Inspectors Mindy M ChouThe inspectors who signed the published document.Inspector lookup

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

Findings

1Other 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.

2Material and supplier control

You used a non-pharmaceutical grade component in the formulation of a drug product.

3Contamination control

You produced hazardous drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.

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.

Healthy Choice Compounding LLC company profile — full history US FDA documents, 2020 Go to Findings search