Inspection Record

Hetero Drugs Ltd. Unit 1 — FDA 483 Findings

US FDAInspected 2018-03-02Published 2018-07-17 5 findingsEquipment and facilityLaboratory and QC controlsDeviation, CAPA, and investigationQuality unit oversightTraining and personnel

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

Findings

1Equipment and facility

There is no assurance that the equipment used in the production of OO a are always maintained and/or kept in/under proper conditions for manufacturing operations and to prevent the contamination of the products handled and/or processed in the equipment.

2Laboratory and QC controls

Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations.

3Deviation, CAPA, and investigation

There is a failure to thoroughly review any unexplained discrepancy and 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.

4Quality unit oversight

The responsibilities and procedures applicable to the quality control unit are not fully followed.

5Training and personnel

Employees engaged in the processing, holding, and testing of a drug product lack the training and experience

About this record

Extracted automatically from the document US FDA published on 2018-07-17. 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.

Hetero Drugs Ltd. Unit 1 company profile — full history US FDA documents, 2018 Go to Findings search