1Data integrity
Your electronic records for your production and process control system do not comply with the electronic records requirements.
Inspection Record
Mylan Laboratories Ltd. — FDA 483 Findings
Inspectors Massoud MotamedThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer 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.
3Material and supplier control
There is a failure to thoroughly review 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.
4Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
5Complaint and recall handling
Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
6Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
About this record
Extracted automatically from the document US FDA published on 2018-06-26. 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.
