Inspection Record

McNeil Consumer and Specialty Pharmaceutical — FDA 483 Findings

US FDAInspected 2015-07-24Published 2024-01-17 5 findingsQuality unit oversightDeviation, CAPA, and investigationProcess validationOther quality system

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Findings

1Quality unit oversight

Changes to written procedures are not reviewed and approved by the quality control unit.

2Deviation, CAPA, and investigation

Written records of investigations into the failure of a batch or any of its components to meet any of its specificationsaff not include the conclusions and followup.

3Process validation

Written production and process control procedures are not followed in the execution of production and process control ; functions.

4Deviation, CAPA, and investigation

Deviations from written sampling plans are not recorded.

5Other quality system

Established sampling plans are not followed.

About this record

Extracted automatically from the document US FDA published on 2024-01-17. 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.

McNeil Consumer and Specialty Pharmaceutical company profile — full history US FDA documents, 2024 Go to Findings search