Inspection Record

XeCare LLC — FDA 483 Findings

US FDAInspected 2026-06-17Published 2026-09-10 3 findingsOther quality systemContamination controlMaterial and supplier control

Inspectors Kara J Wright · Logan T WilliamsThe 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

Use of ingredients not intended for pharmaceutical use in non-sterile drug production.

2Contamination control

Hazardous drugs were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination.

3Material and supplier control

Materials were exposed to lower than ISO 5 quality air.

About this record

Extracted automatically from the document US FDA published on 2026-09-10. 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.

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