1Equipment 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 APT finished materials.
Inspection Record
Shilpa Medicare Limited — FDA 483 Findings
Inspectors Yvins DezanThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer 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.
3Equipment and facility
Equipment used in the manufacture of intermediates and APls is not present within the facility.
About this record
Extracted automatically from the document US FDA published on 2019-08-22. 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.
