1Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not written and followed.
Inspection Record
Ipca Laboratories Limited — FDA 483 Findings
Inspectors Saleem A Akhtar · Wenzheng ZhangThe inspectors who signed the published document.Inspector lookup
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, processing, packing and holding of drug products is not appropriate for the duties they perform.
3Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
4Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Laboratory and QC controls
The suitability of all testing methods is not verified under actual conditions of use.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
About this record
Extracted automatically from the document US FDA published on 2023-07-05. 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.
