1Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Inspection Record
Lupin Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including uten- sils, used in the manufacture, processing, packing or holding of a drug product.
3Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies do not include the conclusions and fol- low-up.
4Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropn- ate design to facilitate operations for its intended use.
5Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
6Documentation and records
The batch production and control records are deficient in that they do not include identification of per- sons performing, supervising and checking each significant step in the operation.
About this record
Extracted automatically from the document US FDA published on 2017-06-02. 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.
