Firm Record

Wedgewood Connect, LLC findings history

17 findings from 3 inspection documents published by regulators. Each row below says what its date means.

US FDA 2022-04-22 ~ 2025-08-08 3 documents 17 findings

Areas cited

Aseptic processing and sterility assuranceTraining and personnelDeviation, CAPA, and investigationQuality unit oversightProcess validationEquipment and facilityStability and storageContamination controlLabeling and packaging

Published inspection documents

2025-08-08 US FDA 5 findingsAseptic processing and sterility assurance · Process validation · Stability and storage · Training and personnel Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. 2024-02-12 US FDA 8 findingsAseptic processing and sterility assurance · Labeling and packaging · Deviation, CAPA, and investigation · Contamination control · Training and personnel · Quality unit oversight Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 2022-04-22 US FDA 4 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Quality unit oversight Procedmes designed to prevent microbiological contamination of drug products purporting to be sterile are not written.

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 Wedgewood Connect, LLC — including inspection classifications Browse by document Go to Findings search