1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Inspection Record
Mylan Laboratories Ltd. — FDA 483 Findings
Inspectors Steven A Brettler · Pratik S UpadhyayThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Actual yield and percentages of theoretical yield are not dete1mined at the conclusion ofeach appropriate phase of manufacturing and processing ofthe diu g product.
3Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the diug product.
4Deviation, 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 aheady distributed.
5Laboratory and QC controls
Laborato1y controls do not include the establishment ofscientifically sound and appropriate sampling plans and test procedures designed to assure that components, in-process materials and dmg products confo1m to appropriate standards of identity, strength, quality and purity.
6Computer 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 2025-01-03. 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.
