1Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in mas- ter production and control records or other records are instituted only by authorized personnel.
Inspection Record
Hetero Labs Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
The written record or copy ofthe record of an investigation of a complaint conducted in relation to any unexplained discrepancy is not maintained at the establishment where the investigation occurred.
3Deviation, CAPA, and investigation
Deviations from production time limits are not documented.
4Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
5Documentation and records
Batch production and control records are not prepared for each batch ofdrug product produced and do not include complete information relating to the production and control ofeach batch Documentation pertaining to exhibit batches submitted to the Agency are incomplete and inaccurate.
6Complaint and recall handling
Written records of investigation ofa drug complaint do not include the findings ofthe investigation and the follow-up.
7Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamina- tion that would alter the safety, identity, strength, quality or purity ofthe drug product.
About this record
Extracted automatically from the document US FDA published on 2017-01-13. 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.
