Firm Record

Carolina Infusion findings history

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

US FDA 2022-11-16 ~ 2025-02-28 3 documents 28 findings

Areas cited

Aseptic processing and sterility assuranceMaterial and supplier controlOther quality systemValidation and qualificationEquipment and facilityTraining and personnelRegulatory reporting and change controlDocumentation and recordsLaboratory and QC controlsContamination controlEnvironmental monitoring

Published inspection documents

2025-02-28 US FDA 6 findingsAseptic processing and sterility assurance · Contamination control · Material and supplier control · Environmental monitoring · Other quality system Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions. 2023-06-13 US FDA 17 findingsLaboratory and QC controls · Equipment and facility · Aseptic processing and sterility assurance · Validation and qualification · Material and supplier control · Regulatory reporting and change control · Other quality system · Training and personnel · Documentation and records You stated in your response that the revised endotoxin test procedure includes the use of single use containers. However, although the revised SOP # 9.170 Version Number 2.0, Serial Dilution for Intrathecal Endotoxin Testing , mentions the use of (b)(4) tubes within the document, it does not indicate that the tubes are single use containers. In addition, you did not provide any supporting training documentation showing your staff were trained on this new procedure, and know how to correctly operate the (b)(4) equipment, or interpret the endotoxin report from the (b)(4) equipment. 2022-11-16 US FDA 5 findingsEquipment and facility · Aseptic processing and sterility assurance · Material and supplier control · Validation and qualification Inadequate pressure differentials between higher quality air rooms and lower quality air rooms were observed.

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 Carolina Infusion — including inspection classifications Browse by document Go to Findings search