Inspection Record

Dr. Reddy's Laboratories Ltd. — FDA 483 Findings

US FDAInspected 2018-03-09Published 2018-03-21 3 findingsComplaint and recall handlingMaterial and supplier controlEquipment and facility

View the regulator's official source The source document is always the basis for judgement.

Findings

1Complaint and recall handling

Procedures describing the handling of written and oral complaints related to AP] materials are not followed.

2Material and supplier control

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.

3Equipment and facility

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.

Other records for this company

Dr. Reddy's Laboratories Ltd. findings history — including this company's other documents US FDA documents, 2018 Go to Findings search