Inspection Record

SKNV — FDA 483 Findings

US FDAInspected 2025-03-06Published 2025-03-28 3 findingsContamination controlLabeling and packagingDeviation, CAPA, and investigation

Inspectors Jennifer LalamaThe inspectors who signed the published document.Inspector lookup

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Findings

1Contamination control

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

2Labeling and packaging

The container of your outsourcing facility's drug products does not include information required by section 503B(a)(10)(B) of the Federal Food, Drug and Cosmetic Act (FD&CAct).

3Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

About this record

Extracted automatically from the document US FDA published on 2025-03-28. 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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