Inspection Record

Professional Arts Pharmacy — FDA 483 Findings

US FDAInspected 2018-02-26Published 2024-01-17 3 findingsOther quality systemContamination controlMaterial and supplier control

Inspectors Djamila Harouaka · Sena G. Z. DissmeyerThe 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.

2Contamination control

You produced highly potent or hazardous drugs without providing adequate cleaning of work surfaces and utensils to prevent cross-contamination.

3Material and supplier control

Non-pharmaceutical grade components are used in the formulation of non-sterile drug products.

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.

Other records for this company

2016-04-22 · US FDA · 6 findings
Professional Arts Pharmacy findings history — including this company's other documents US FDA documents, 2024 Go to Findings search