Inspection Record

Indoco Remedies Limited — FDA 483 Findings

US FDAInspected 2019-01-25Published 2019-02-12 5 findingsDeviation, CAPA, and investigationDocumentation and recordsEquipment and facilityLaboratory and QC controls

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

Findings

1Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

2Documentation and records

Procedures for the preparation of master production and control records are not described in a written procedure.

3Equipment and facility

Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.

4Laboratory and QC controls

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

5Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

About this record

Extracted automatically from the document US FDA published on 2019-02-12. 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.

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