1Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Inspection Record
Aurobindo Pharma Ltd. Telangana — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
3Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.
4Stability and storage
Drug product expiration dates are not related to the storage conditions stated on the labeling, as determined by stability studies.
5Complaint and recall handling
Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
6Other quality system
A sample which is representative of each lot in each shipment of each active ingredient is not appropriately identified and retained.
7Computer system validation
Backup data is not assured as secure from alteration, erasure or loss through keeping hard copy or alternate systems.
8Equipment and facility
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
9Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
About this record
Extracted automatically from the document US FDA published on 2019-06-10. 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.
