Firm Record

Cantrell Drug Company findings history

65 findings from 7 inspection documents published by regulators. Each row below says what its date means.

US FDA 2019-04-30 ~ 2024-01-17 7 documents 65 findings

Areas cited

Aseptic processing and sterility assuranceEquipment and facilityStability and storageDeviation, CAPA, and investigationLabeling and packagingOther quality systemLaboratory and QC controlsComplaint and recall handlingMaterial and supplier controlQuality unit oversightTraining and personnelRegulatory reporting and change controlComputer system validation

Published inspection documents

2024-01-17 US FDA 11 findingsOther quality system · Training and personnel · Complaint and recall handling · Laboratory and QC controls · Material and supplier control · Aseptic processing and sterility assurance · Equipment and facility · Stability and storage · Quality unit oversight Drug product containers and closures were not clean to assure that they are suitable for their intended use. 2024-01-17 US FDA 7 findingsLabeling and packaging · Complaint and recall handling · Deviation, CAPA, and investigation · Aseptic processing and sterility assurance · Material and supplier control · Other quality system · Regulatory reporting and change control The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A). 2024-01-17 US FDA 8 findingsOther quality system · Deviation, CAPA, and investigation · Labeling and packaging · Aseptic processing and sterility assurance · Quality unit oversight · Stability and storage we identifie d that thi s exact lot was subject to an environmental excursion documented in the "Summar y an d Analysi s of Area <Redacted B4> Env iron ment and Gown ing Data for Ma y 201 7". 2024-01-17 US FDA 12 findingsStability and storage · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Equipment and facility · Labeling and packaging · Laboratory and QC controls There is no written testing program designed to assess the stability characteristics of dm g products. 2024-01-17 US FDA 12 findingsEquipment and facility · Other quality system · Aseptic processing and sterility assurance · Deviation, CAPA, and investigation · Labeling and packaging · Stability and storage · Laboratory and QC controls The building lacks adequate space for the orderly placement of equipment and materials to prevent mix- ups between different components, drug product containers, labeling, in-process materials and drug products and to prevent contamination. 2024-01-17 US FDA 12 findingsAseptic processing and sterility assurance · Laboratory and QC controls · Labeling and packaging · Deviation, CAPA, and investigation · Stability and storage · Equipment and facility Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters lmder positive pressure. 2019-04-30 US FDA 3 findingsEquipment and facility · Computer system validation Equipment for adequate control over humidity is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.

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 Cantrell Drug Company — including inspection classifications Browse by document Go to Findings search