1Laboratory and QC controls
Your firm failed to use validated and stability-indicating test procedures.
Inspection Record
SNJ Labs Private Ltd. — FDA 483 Findings
Inspectors Paranthaman Senthamarai KannanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Failure to follow and document laboratory controls at the time of performance and failure to document and explain any departures from laboratory procedures.
3Equipment and facility
Failure to properly maintain buildings and facilities used in the manufacture of API.
4Computer system validation
Your firm failed to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data and failure to have adequate controls to prevent omission of data.
5Material and supplier control
Failure to have adequate written procedures for the sampling of raw materials.
About this record
Extracted automatically from the document US FDA published on 2026-08-05. 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.
