Inspection Record

Pharmaneek Inc — FDA 483 Findings

US FDAInspected 2026-04-08Published 2026-06-22 3 findingsEquipment and facilityOther quality systemContamination control

Inspectors Janet A. RajanThe inspectors who signed the published document.Inspector lookup

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

Findings

1Equipment and facility

Your facility is not maintained in a good state of repair, creating insanitary conditions whereby drug products may be contaminated with filth.

2Other quality system

Your firm failed to confirm that the quality of water was suitable for its intended use in the production of non-sterile drug products.

3Contamination control

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

About this record

Extracted automatically from the document US FDA published on 2026-06-22. 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.

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