1Equipment and facility
Adequate, clean washing and toilet facilities are not provided for personnel.
Inspection Record
Badrivishal Chemicals & Pharmaceuticals — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory records do not include complete data derived from all tests and examinations necessary to assure compliance with established specifications and standards.
3Computer system validation
Computerized systems do not have sufficient controls to prevent unauthorized access or changes to data.
4Laboratory and QC controls
Test procedures are not fully documented at the time ofperformance.
5Laboratory and QC controls
Complete records documenting the suitability ofcompendial test methods are not maintained.
6Training and personnel
Appropriate controls are not exercised to assure that changes to documents related to the manufacture of intermediates or APIs are instituted only by authorized personnel.
7Laboratory and QC controls
Laboratory control mechanisms are not scientifically sound and appropriate to ensure that raw materials,
About this record
Extracted automatically from the document US FDA published on 2017-05-11. 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.
