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. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Deviation, 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.
3Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
4Process validation
Control procedures are not established which of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Process validation
There are no written procedures for production and process controls designed to assure that the drug products have identity, strength, quality, and purity they purport or are represented to possess.
7Process validation
Written production and process controls procedures are not followed in the execution of production and process control functions.
About this record
Extracted automatically from the document US FDA published on 2019-10-09. 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.
