1Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Inspection Record
Sun Pharmaceutical Industries Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Appropriate controls are not exercised to assure that changes to documents related to the manufacture of drug products are instituted only by authorized personnel.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
4Complaint and recall handling
Field Alert Reports were not submitted within three working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.
5Other quality system
Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational units.
6Stability and storage
Testing programs are not adequately designed to assess the stability characteristics of drug products.
7Laboratory and QC controls
Scientifically sound and appropriate laboratory contro!
8Quality unit oversight
The establishment of test procedures, including any changes thereto, are not adequately reviewed and approved by the quality control unit.
About this record
Extracted automatically from the document US FDA published on 2016-12-13. 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.
