1Other quality system
Back-up data is not appropriately protected from unauthorized access, manipulation or deletion.
Inspection Record
Hikal Limited — FDA 483 Findings
Inspectors Marcellinus D DordunooThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer system validation
Incidents related to computerized systems that could affect the quality of intermediates or APIs are not recorded and investigated.
3Equipment and facility
Appropriate ~aintenance and calibration ofcritical equipment is not performed.
4Other quality system
Out-Of-Specification (OOS) results are routinely invalidated, without sufficient supporting evidence or scientific justification ofthe root cause.
5Other quality system
Written procedures are deficient specifically A.
About this record
Extracted automatically from the document US FDA published on 2026-04-03. 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.
