1Other quality system
Procedures for acceptance of incoming product have not been adequately established.
Inspection Record
Lupin Limited Unit III — FDA 483 Findings
Inspectors Yasamin AmeriThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Sampling procedures are deficient regarding sampling components from the top, middle, and bottom of container.
3Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
4Equipment and facility
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessaiy to assure proper cleaning and maintenance and instmctions for removal or obliteration of previous batch identification.
5Process validation
Control procedures are not established which monitor the output and validate the perfonnance of those manufacturing processes that may be responsible for causing variability in the characteristics of in- process material and the diu g product.
About this record
Extracted automatically from the document US FDA published on 2018-11-05. 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.
