Procedures describing the handling of written and oral complaints related to AP] materials are not followed.
Inspection Record
Dr. Reddy's Laboratories Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of API finished materials prior to release.
Buildings used in the manufacturing, processing, packing of API finished materials are not maintained in a good state of repair.
About this record
Extracted automatically from the document US FDA published on 2018-03-21. 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.
