Firm Record

McNeil Consumer Healthcare findings history

68 findings from 6 inspection documents published by regulators. Each row below says what its date means.

US FDA 2024-01-17 ~ 2024-01-17 6 documents 68 findings

Areas cited

Deviation, CAPA, and investigationQuality unit oversightOther quality systemComplaint and recall handlingLaboratory and QC controlsProcess validationDocumentation and recordsEquipment and facilityMaterial and supplier controlLabeling and packagingTraining and personnelStability and storageValidation and qualification

Published inspection documents

2024-01-17 US FDA 7 findingsComplaint and recall handling · Deviation, CAPA, and investigation · Process validation · Quality unit oversight Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. 2024-01-17 US FDA 3 findingsLaboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight The responBibilities and procedures applicable to the quality control u~t are not fully f~llowed. 2024-01-17 US FDA 13 findingsEquipment and facility · Laboratory and QC controls · Deviation, CAPA, and investigation · Quality unit oversight · Labeling and packaging · Other quality system · Documentation and records · Material and supplier control · Complaint and recall handling Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. 2024-01-17 US FDA 20 findingsProcess validation · Equipment and facility · Laboratory and QC controls · Labeling and packaging · Training and personnel · Quality unit oversight · Material and supplier control · Other quality system · Deviation, CAPA, and investigation · Stability and storage · Documentation and records · Complaint and recall handling There are no written procedures for production and process controls designed to assure that the drug products have the identity, strenght, quality, and purity they purport or are represented to possess Specifically, Lack of process valida tio n f or the manufacture of Infant's Dye-Fr ee tyl enol susp ension dro ps, cherry, fo rmula REDACTED (b) (4) 80 ml/0.8 mL. 2024-01-17 US FDA 5 findingsValidation and qualification · Deviation, CAPA, and investigation · Other quality system The approved Qualification protocor for qualifying the new and upgraded ~ compression machines is ...,' missing. 2024-01-17 US FDA 20 findingsEquipment and facility · Documentation and records · Process validation · Other quality system · Material and supplier control · Laboratory and QC controls · Quality unit oversight · Stability and storage · Training and personnel · Labeling and packaging · Complaint and recall handling · Deviation, CAPA, and investigation The persons double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.

About this page

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.

What is included. As of 2026-09-03, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.

Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.

Full history of McNeil Consumer Healthcare — including inspection classifications Browse by document Go to Findings search