1Other quality system
Drug prndud ~amples are uor representative of the entire batch and properly identified A.
Inspection Record
Shilpa Medicare Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent nlicrobiological contamination of drng products purporting to be sterile are not established or follov>ed.
3Laboratory and QC controls
Laboratory contw ls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform tu appropriate standards of identity, stTength.
4Other quality system
Control procedures ar..: not established 'v\.
5Equipment and facility
Records of the calibration checks and inspection:; of automatic.
About this record
Extracted automatically from the document US FDA published on 2020-04-02. 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.
