Firm Record

ProRx LLC findings history

69 findings from 4 inspection documents published by regulators. Each row below says what its date means.

US FDA 2024-09-26 ~ 2026-05-12 4 documents 69 findings

Areas cited

Aseptic processing and sterility assuranceDeviation, CAPA, and investigationEquipment and facilityQuality unit oversightDocumentation and recordsStability and storageContamination controlMaterial and supplier controlLabeling and packagingEnvironmental monitoringTraining and personnelRegulatory reporting and change controlOther quality systemLaboratory and QC controls

Published inspection documents

2026-05-12 US FDA 15 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Environmental monitoring · Equipment and facility · Documentation and records · Quality unit oversight · Contamination control An operator blocked first air by placing gloved hands and/or forearms directly over open tray of stoppers intended to be sterile during critical in-process operations within the ISO 5 production areas. 2025-12-15 US FDA 7 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Labeling and packaging · Laboratory and QC controls Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions. 2025-03-04 US FDA 34 findingsOther quality system · Equipment and facility · Environmental monitoring · Stability and storage · Contamination control · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Documentation and records · Material and supplier control · Quality unit oversight The procedure outlined in your SOP #: ProSOP-B090, Rev. 00, appears contradictory. Step 7.1.4 within the SOP, states that the BSC (b)(4) . However, the instruction in step 7.1.5 states to turn off the blower prior to and during the sanitization of the BSC. You did not provide any scientific justification or data to support this practic e. 2024-09-26 US FDA 13 findingsAseptic processing and sterility assurance · Quality unit oversight · Training and personnel · Stability and storage · Material and supplier control · Equipment and facility · Regulatory reporting and change control · Labeling and packaging · Deviation, CAPA, and investigation Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

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 ProRx LLC — including inspection classifications Browse by document Go to Findings search