Firm Record

Auro Pharmacies, Inc. findings history

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

US FDA 2024-01-17 ~ 2024-01-17 6 documents 65 findings

Areas cited

Aseptic processing and sterility assuranceStability and storageLaboratory and QC controlsMaterial and supplier controlDeviation, CAPA, and investigationQuality unit oversightTraining and personnelEquipment and facilityOther quality systemContamination controlValidation and qualification

Published inspection documents

2024-01-17 US FDA 9 findingsAseptic processing and sterility assurance · Quality unit oversight · Deviation, CAPA, and investigation · Training and personnel · Laboratory and QC controls · Stability and storage Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and foll owed. 2024-01-17 US FDA 8 findingsAseptic processing and sterility assurance · Validation and qualification · Other quality system · Equipment and facility · Stability and storage · Material and supplier control Media fills were not performed that closely simulate aseptic production operations incorporating, as appropriate, worst-case activities and conditions that provide a challenge to aseptic operations. 2024-01-17 US FDA 9 findingsAseptic processing and sterility assurance · Other quality system · Material and supplier control · Equipment and facility · Stability and storage Personnel conducted aseptic manipulations in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product. 2024-01-17 US FDA 11 findingsDeviation, CAPA, and investigation · Quality unit oversight · Aseptic processing and sterility assurance · Laboratory and QC controls · Equipment and facility · Stability and storage Written.records are not always made ofinvestigations into unexplained discrepancies and the failure of a batch or any. 2024-01-17 US FDA 14 findingsDeviation, CAPA, and investigation · Laboratory and QC controls · Quality unit oversight · Stability and storage · Training and personnel · Material and supplier control · Aseptic processing and sterility assurance · Contamination control Written records are not always made of investigations into unexplained discrepancies. 2024-01-17 US FDA 14 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Training and personnel · Deviation, CAPA, and investigation · Contamination control · Material and supplier control · Quality unit oversight · Stability and storage 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 Auro Pharmacies, Inc. — including inspection classifications Browse by document Go to Findings search