Firm Record

Catalent Indiana LLC findings history

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

US FDA 2022-10-19 ~ 2026-07-17 6 documents 44 findings

Areas cited

Aseptic processing and sterility assuranceProcess validationDeviation, CAPA, and investigationEquipment and facilityQuality unit oversightMaterial and supplier controlOther quality systemDocumentation and recordsLaboratory and QC controlsComplaint and recall handling

Published inspection documents

2026-07-17 US FDA 8 findingsAseptic processing and sterility assurance · Documentation and records · Equipment and facility · Deviation, CAPA, and investigation · Quality unit oversight · Material and supplier control · Process validation Aseptic processing areas are deficient regarding the system for monitoring environmental conditions, Specifically, Environmental monitoring is not always performed in response to interventions located and / or impacting critical surfaces. 2026-07-08 US FDA 8 findingsQuality unit oversight · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility · Process validation · Documentation and records · Material and supplier control The responsibilities and procedures applicable to the quaJity unit are not in writing and fully followed. 2025-12-15 US FDA 6 findingsAseptic processing and sterility assurance · Deviation, CAPA, and investigation · Quality unit oversight · Process validation · Material and supplier control Aseptic processing areas ai·e deficient regai·ding the system for monitoring environmental conditions. 2024-03-22 US FDA 6 findingsQuality unit oversight · Process validation · Laboratory and QC controls · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Equipment and facility The responsibilities and procedures applicable to the quality control unit are not fully followed. 2023-07-21 US FDA 5 findingsOther quality system · Aseptic processing and sterility assurance In-proc.es.s sampJes are not fel'.JFCS4.mlativ~. 2022-10-19 US FDA 11 findingsOther quality system · Equipment and facility · Aseptic processing and sterility assurance · Process validation · Complaint and recall handling · Laboratory and QC controls · Deviation, CAPA, and investigation Records are not maintained so that data therein can be reviewed at least <Redacted B4> to evaluate the quality standards of each drug product to determine the need for changes in specifications or manufacturing or control procedures.

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