1Other quality system
Warehouse procedure is not followed.
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
Clothing of personnel engaged in the manufacturing of drug products is not appropriate for the duties they perform.
3Equipment and facility
Routine checking of electronic equipment is not performed according to a written program to ensure proper performance.
4Documentation and records
Batch production and control records for each batch ofdrug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.
5Equipment and facility
Adequate lighting is not provided in all area Specifically during the walk through, we observed the firm’s raw material warehouse RM-11 was not adequately lit.
6Quality unit oversight
The quality control unit lacks the authority to review production records to assure that no errors have occurred.
7Complaint and recall handling
Control Procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process and the drug products Specifically, the firm has been receiving numerous customer complaints regarding over fill and under fill tablets ranging from one to sixty-three since 2015.
8Deviation, CAPA, and investigation
Written records of investigation into unexplained discrepancies or the failure ofa batch or its components to meet specification do not always include Conclusion and follow up Specifically, the following lab events were not investigated to assess the Root Cause, also no Correctiv...
9Quality unit oversight
Each lot ofdrug product is not withheld from use in quarantine before release from the quality control unit.
10Training and personnel
Employees are not given training in written procedure required by current good manufacturing practices regulation.
About this record
Extracted automatically from the document US FDA published on 2017-04-21. 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.
