Firm Record

AnazaoHealth Corporation findings history

52 findings from 8 inspection documents published by regulators. Each row below says what its date means.

US FDA 2019-11-27 ~ 2025-09-02 8 documents 52 findings

Areas cited

Aseptic processing and sterility assuranceProcess validationRegulatory reporting and change controlTraining and personnelLaboratory and QC controlsMaterial and supplier controlEquipment and facilityDeviation, CAPA, and investigationOther quality systemComplaint and recall handlingStability and storageContamination controlLabeling and packagingQuality unit oversightEnvironmental monitoring

Published inspection documents

2025-09-02 US FDA 4 findingsAseptic processing and sterility assurance · Complaint and recall handling · Process validation · Laboratory and QC controls Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. 2024-01-17 US FDA 14 findingsContamination control · Aseptic processing and sterility assurance · Process validation · Other quality system · Environmental monitoring · Quality unit oversight · Material and supplier control Personnel engaged in the making ofradiopharmaceuticals in the Nuclear Pharmacy failed to wear appropriate protective apparel to protect the drug product from contamination. 2024-01-17 US FDA 4 findingsAseptic processing and sterility assurance · Regulatory reporting and change control · Labeling and packaging Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. 2024-01-17 US FDA 12 findingsAseptic processing and sterility assurance · Material and supplier control · Equipment and facility · Training and personnel · Stability and storage · Laboratory and QC controls · Process validation Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. 2024-01-17 US FDA 6 findingsAseptic processing and sterility assurance · Training and personnel · Deviation, CAPA, and investigation · Regulatory reporting and change control Procedures designed to prevent microbiological contamination of drug purporting to be sterile do not include adequate validation of the sterilization process. 2024-01-17 US FDA 6 findingsTraining and personnel · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Regulatory reporting and change control Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for th e duties they perform. 2022-11-21 US FDA 3 findingsMaterial and supplier control · Process validation · Laboratory and QC controls There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. 2019-11-27 US FDA 3 findingsRegulatory reporting and change control · Equipment and facility · Aseptic processing and sterility assurance Bulk drug substances used by your outsourcing facility to compound drug products are not each manufactured by an establishment that is registered under section 510 of the FDCA as required by section 503(a)(2)(C).

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 AnazaoHealth Corporation — including inspection classifications Browse by document Go to Findings search