Firm Record

H & P Industries, Inc. findings history

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

US FDA 2024-01-17 ~ 2024-01-17 7 documents 137 findings

Areas cited

Process validationDeviation, CAPA, and investigationOther quality systemEquipment and facilityLaboratory and QC controlsQuality unit oversightTraining and personnelAseptic processing and sterility assuranceContamination controlMaterial and supplier controlComplaint and recall handlingStability and storageComputer system validationLabeling and packagingRegulatory reporting and change controlDocumentation and recordsValidation and qualification

Published inspection documents

2024-01-17 US FDA 10 findingsEquipment and facility · Laboratory and QC controls · Process validation · Other quality system · Deviation, CAPA, and investigation Equipment for adequate control over air pressure and dust is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. 2024-01-17 US FDA 9 findingsEquipment and facility · Laboratory and QC controls · Process validation · Deviation, CAPA, and investigation Written procedures are not followed for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. 2024-01-17 US FDA 46 findingsProcess validation · Other quality system · Aseptic processing and sterility assurance · Documentation and records · Laboratory and QC controls · Contamination control · Quality unit oversight · Stability and storage · Material and supplier control · Equipment and facility · Deviation, CAPA, and investigation · Training and personnel · Complaint and recall handling · Validation and qualification Written production and process control procedures are not documented at the time of performance. 2024-01-17 US FDA 18 findingsEquipment and facility · Material and supplier control · Laboratory and QC controls · Labeling and packaging · Quality unit oversight · Deviation, CAPA, and investigation · Other quality system · Process validation · Computer system validation · Contamination control Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product. 2024-01-17 US FDA 17 findingsMaterial and supplier control · Deviation, CAPA, and investigation · Other quality system · Contamination control · Computer system validation · Labeling and packaging · Equipment and facility · Training and personnel · Process validation · Quality unit oversight Rejected in-process materials are not identified and controlled under a quarantine system to prevent their use in manufacturing or processing operations for which they are unsuitable. 2024-01-17 US FDA 14 findingsAseptic processing and sterility assurance · Quality unit oversight · Other quality system · Deviation, CAPA, and investigation · Process validation Proccdurcs designed to prevaIt mic:robiologic:al COIdaIIIin.aioD ofdrug products purportjDg to be sterile do DOt include validation oftbe sterilizatioo process. 2024-01-17 US FDA 23 findingsEquipment and facility · Other quality system · Deviation, CAPA, and investigation · Regulatory reporting and change control · Laboratory and QC controls · Stability and storage · Aseptic processing and sterility assurance · Quality unit oversight · Process validation · Complaint and recall handling · Training and personnel Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or pw-ity of the 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 H & P Industries, Inc. — including inspection classifications Browse by document Go to Findings search