Inspection Record

Wockhardt Limited — FDA 483 Findings

US FDAInspected 2015-12-15Published 2017-01-26 8 findingsEquipment and facilityAseptic processing and sterility assuranceComputer system validationDeviation, CAPA, and investigationQuality unit oversightValidation and qualificationOther quality system

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

Findings

1Equipment and facility

Buildings and facilities used in the manufacture of intermediates and APIs should be constructed to facilitate

2Aseptic processing and sterility assurance

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not

3Computer system validation

Computerized systems shall be validated and the depth and scope of the validation depends on the diversity, complexity, and criticality of the computerized application.

4Deviation, CAPA, and investigation

Deviations from approved standards of calibration on critical instruments shall be investigated to determine if these could have had an effect on the quality of the intermediate(s) or API(s) tested since the last successful calibration.

5Quality unit oversight

Proposals for GMP relevant changes shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality unit.

6Computer system validation

Computerized systems shall have sufficient controls to prevent unauthorized access or changes to data.

7Validation and qualification

Analytical methods shall be validated to include consideration of the characteristics included in the validation of analytical methods.

8Other quality system

Record entries documenting your operations shall be made contemporaneously and permanently in spaces provided for such entries, and should identify the person making the entry.

About this record

Extracted automatically from the document US FDA published on 2017-01-26. 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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