Firm Record

Impax Laboratories, Inc. findings history

17 findings from 2 inspection documents published by regulators. Each row below says what its date means.

US FDA 2024-01-17 ~ 2024-01-17 2 documents 17 findings

Areas cited

Process validationOther quality systemDeviation, CAPA, and investigationTraining and personnelDocumentation and recordsComplaint and recall handlingEquipment and facilityLaboratory and QC controlsStability and storageMaterial and supplier controlComputer system validation

Published inspection documents

2024-01-17 US FDA 5 findingsOther quality system · Deviation, CAPA, and investigation · Process validation Written procedures for sampling and testing plans are not followed for each drug product. View the regulator's official source
2024-01-17 US FDA 12 findingsDocumentation and records · Complaint and recall handling · Stability and storage · Computer system validation · Material and supplier control · Deviation, CAPA, and investigation · Laboratory and QC controls · Equipment and facility · Other quality system · Training and personnel · Process validation Batch production and control records do not include complete information relating to the production and control of each b atch. View the regulator's official source

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 2026-10-20, 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 Impax Laboratories, Inc. — including inspection classifications Browse by document Go to Findings search
Weekly Newsletter

Get new findings like these every Monday

Every Monday we email the week's new findings and actions from the FDA, EMA, Health Canada and MFDS. Each one links to its record on our site, where you'll find the regulator's original document. We'll also let you know when the site gains new features. Unsubscribe any time with one click.

See recent findings first

Sent every Monday · a confirmation email follows when you subscribe · unsubscribe from the footer of any email.