Inspection Record

McNeil Consumer Healthcare — FDA 483 Findings

US FDAInspected 2015-07-24Published 2024-01-17 3 findingsLaboratory and QC controlsDeviation, CAPA, and investigationQuality unit oversight

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

Findings

1Laboratory and QC controls

The responBibilities and procedures applicable to the quality control u~t are not fully f~llowed.

2Deviation, CAPA, and investigation

There is a failure to thoroughly tevi~w any unexplained discrepancy whether -or not the batch has been thoroughly distributed.

3Quality unit oversight

The establishment ofl.ahoratory contrQ!.mec1:).~~~ inclp.ding; Einy changes thereto, are not reviewed and approved by the quality control unit.

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.

Other records for this company

2015-07-10 · US FDA · 7 findings2015-07-10 · US FDA · 13 findings2015-07-23 · US FDA · 20 findings2015-07-11 · US FDA · 5 findings2015-07-23 · US FDA · 20 findings
McNeil Consumer Healthcare company profile — full history US FDA documents, 2024 Go to Findings search