1Laboratory and QC controls
Laboratory control does not include establishment of scientifically sound and appropriate test procedures and specifications designed to assure quality of drug substances.
Inspection Record
Alembic Pharmaceuticals Limited Units I & II — FDA 483 Findings
Inspectors Pratik S. UpadhyayThe 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
Laboratory investigations were not conducted timely based on an identifiable trend or thoroughly to determine the root cause.
3Equipment and facility
Equipment is not cleaned and maintained to prevent contamination that would alter the safety, identity, strength, quality and purity of the drug product.
4Quality unit oversight
Lack of Quality Unit oversight on document control and review.
About this record
Extracted automatically from the document US FDA published on 2025-11-03. 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.
