1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of diug products purpo1i ing to be sterile are not written and followed.
Inspection Record
Zydus Lifesciences Limited — FDA 483 Findings
Inspectors Sean R Marcsisin · Lori M NewmanThe 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 and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drng product.
3Equipment and facility
Buildings used in the manufacturing, processing, packing and holding ofa drng product are not maintained in a good state of repair.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2024-04-12. 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.
