1Cleaning validation
Employees are not trained in cleaning procedures.
Inspection Record
Zen Chemicals Pvt. Ltd — FDA 483 Findings
Inspectors Dipesh ShahThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment are not cleaned and sanitized to prevent contamination of the critical API intermediate product.
3Deviation, CAPA, and investigation
No investigations are conducted to evaluate all potential root causes ofmultiple sample results.
4Equipment and facility
Qualification of equipment were not performed.
5Laboratory and QC controls
Appropriate controls governing computer acquired data and/or related systems have not been established to assure that changes and access to computerized software for the laboratory control system is accessed only by authorized personnel.
About this record
Extracted automatically from the document US FDA published on 2026-10-19. 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.
