1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Inspection Record
Micro Labs Limited — FDA 483 Findings
Inspectors Pratik S Upadhyay · Timothy H VoThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, CAPA, and investigation
Deviations from written test procedures and laborato1y mechanisms are not recorded and justified.
3Laboratory and QC controls
Laborato1y controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and diug products confo1m to appropriate standards of identity, quality and purity.
4Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, sb.'ength, quality or purity of the diug product.
About this record
Extracted automatically from the document US FDA published on 2026-03-25. 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.
