Inspection Record

SNF Holdings LLC — FDA 483 Findings

US FDAInspected 2023-03-02Published 2023-09-27 3 findingsContamination controlMaterial and supplier control

Inspectors Jacob G Lutz · Alan M Barker · Wen Ning ChanThe 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

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

2Material and supplier control

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

3Contamination control

Non-microbial contamination was observed in your production area.

About this record

Extracted automatically from the document US FDA published on 2023-09-27. 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.

SNF Holdings LLC company profile — full history US FDA documents, 2023 Go to Findings search