Recently, the State Food and Drug Administration organized an inspection team to conduct unannounced inspections on three companies including Tianjin Soma Technology Co., Ltd., and found defects in the quality management system of the companies. Details are as follows:
1. Tianjin Soma Technology Co., Ltd.
(1) Institutions and personnel
Insufficient ability of inspectors to perform their duties: the company only has two full-time inspectors, one of whom is a newly transferred employee. This person only has raw material and process inspection training records, but no finished product inspection training records; Staphylococcus aureus was not established as required , Limulus reagent and other testing reagents and strains of purchase, use and destruction records; failed to retain samples for peripheral balloon dilatation catheters as required, and did not retain samples for observation of the disposable arterial vascular sheath group. Personnel who do not comply with the “Quality Management Standards for Medical Device Production” and “Appendix Sterile Medical Devices for Good Manufacturing Practices for Medical Devices” (hereinafter referred to as the “Specifications” and the Sterile Appendix) and are engaged in work that affects product quality shall pass the qualifications that are suitable for their positions. Training, with relevant theoretical knowledge and practical skills required.
(2) Procurement management
The company has not signed a quality agreement with major raw material suppliers such as outer sheath tubes, syringes, and skin-breaking knives to clarify the quality responsibilities of both parties. If it does not conform to the “Specifications” and the sterile appendix, a quality agreement should be signed with the main raw material supplier to clarify the quality responsibilities assumed by both parties.
(3) Production management
a. The document numbers of each process operating procedure marked in the “Peripheral Balloon Dilation Catheter Production Operation Instructions” formulated by the enterprise do not match the actual document numbers, and are not completely consistent with the document numbers registered in the “Process Flow Card”; The process parameter card of the balloon stretching process; the original data records in the process verification report of key processes such as hydrophilic coating and distal/proximal welding are incomplete and do not conform to the “Specifications” and the production process regulations should be compiled in the sterile appendix. Work instructions, etc., to clarify the requirements of key processes and special processes.
b. On-site random inspection of a certain batch of peripheral balloon dilatation catheter batch production records failed to meet the traceability requirements: the person who signed the process inspection of the procedures such as distal/proximal welding and balloon assembly was inconsistent with the person recording the process card; The cleaning and drying records of relevant raw materials (accessories) do not show the batch numbers of raw materials; the operation time registered in the proximal welding process card is earlier than the operation time of the hydrophilic coating of the outer tube used in this process, which does not comply with the “Specifications” and the sterile appendix Each batch of products should have production records and meet the traceability requirements.
c. On-site inspection found that there were a large number of semi-finished inner sheath tubes stacked on the shelves in the extrusion room of the clean area without any label identification, and the production time, quantity and inspection status could not be determined. It does not meet the requirements in the “Specifications” and the sterile appendix that the inspection status of the product should be marked during the production process to prevent unqualified intermediate products from flowing to the next process.
(4) Quality control
The “Peripheral Balloon Dilatation Catheter Finished Product Inspection Operation Instructions” formulated by the enterprise does not cover the items such as the catheter seat conical joint, hydration determination, and ray detectability in the product technical requirements; the product delivery inspection stipulated in the “Sterile Inspection Operation Procedures” The selection of biological indicator culture as the basis for product sterility testing is inconsistent with the testing method stipulated in the product technical requirements, and does not conform to the “Specifications” and the sterile appendix should formulate the product’s certification based on mandatory standards and registered or filed product technical requirements. Inspection procedures, and the requirements for issuing corresponding inspection reports or certificates.
The enterprise’s quality management system has serious defects and does not meet the relevant requirements of the “Quality Management Regulations for Medical Device Production”. The enterprise has confirmed the above defects in its quality management system.
The Tianjin Drug Administration shall, in accordance with Article 72 of the “Regulations on the Supervision and Administration of Medical Devices”, take control measures to suspend production of the enterprise in accordance with the law, and shall, in accordance with the law, Deal with it, and order the company to assess product safety risks, and recall related products in accordance with the “Medical Device Recall Management Measures” for those that may cause safety hazards.
The enterprise can resume production only after completing all project rectifications and passing the re-examination by the Tianjin Drug Administration.
2. Shenzhen Ante Medical Co., Ltd.
(1) Plant and facilities
The inspection found that the company stored the outer packaging boxes, labels, and finished products of dental implant system products on the 6th floor of the factory area, and other items such as expired samples, returned products, and production waste, as well as the packaging boxes, labels, and basic products of its affiliated dental related products. Taiwan finished products and other items, as well as other idle production equipment and sundries, are not equipped with temperature and humidity control, rodent prevention and other related facilities and equipment, have no product and material flow records, and have not carried out warehouse partition management. This area has not been included in the warehouse management of the enterprise quality management system. , does not comply with the “Quality Management Standards for Medical Device Production” and “Appendix Implantable Medical Devices for Medical Device Production Quality Control Standards” (hereinafter referred to as the “Specifications” and the Implantation Appendix). Plants and facilities should be based on the characteristics, process and The corresponding cleanliness level requires reasonable design, layout and use requirements.
(2) Procurement management
The enterprise entrusts its affiliated company to purchase and process metal materials for dental implant system products, but fails to provide the quality assurance agreement on outsourced processing of the machining process between the two parties. The supplier signs a quality agreement to clarify the requirements for quality responsibilities undertaken by both parties.
(3) Production management
a. Sampling inspection of the “Acid Etching Process Confirmation Report” of the enterprise. The content of this document is actually the confirmation of the water bath equipment. The enterprise failed to provide the acid etching process verification record. It does not comply with the “Specifications” and the implantation appendix should prepare the production process regulations and operation instructions. etc., clarify the requirements of key processes and special processes.
b. A spot check of a batch of dental implant system product batch production records shows that the actual operator of the sandblasting and acid etching process is inconsistent with the signatory in the production records, and the company has shared employees with its affiliated companies, which does not comply with the “Specifications” and the implantation system. When the appendix specifies the records of traceability requirements, it shall include the requirements for the records of raw materials used, production equipment, operators and production environment that may cause the final product to fail to meet the specified requirements.
(4) Quality control
The enterprise entrusts a company to sterilize dental implant system products by irradiation. Check the batch production records of a certain batch of products of the company, and the “Irradiation Certificate” included in it shows that the date of irradiation sterilization inspection is earlier than the end date of irradiation. The company has not stipulated the release standard of the sterilization process, and has not identified the risk. , the enterprise releases and sells the batch of products after passing the sterility test. If it does not meet the requirements of the “Specifications” and the implantation appendix, the product release procedures, conditions and release approval requirements shall be stipulated.
The enterprise’s quality management system has serious defects and does not meet the relevant requirements of the “Quality Management Regulations for Medical Device Production”. The enterprise has confirmed the above defects in its quality management system.
The Guangdong Provincial Drug Administration shall, in accordance with Article 72 of the “Regulations on the Supervision and Administration of Medical Devices”, take control measures to suspend production of the enterprise according to law, and shall, in accordance with the law, Deal with it, and order the company to assess product safety risks, and recall related products in accordance with the “Medical Device Recall Management Measures” for those that may cause safety hazards.
The enterprise can resume production only after completing all project rectifications and passing the re-examination by the Guangdong Provincial Drug Administration.
3. Beijing Datang Dingshi Eye Care Products Co., Ltd.
As the registrant, the company entrusted an enterprise in Hunan Province to produce soft hydrophilic contact lenses in December 2019, and canceled the company’s medical device production license in December 2020, and submitted a report to the Beijing Drug Administration in September 2022. Application for discontinuation of production and cancellation of commissioned production. During the unannounced inspection, the enterprise is in a state of suspension of production, the main management personnel are no longer in the enterprise, the enterprise management representative cannot fulfill the responsibility of establishing, implementing and maintaining the effective operation of the quality management system, and the management representative should Responsible for establishing, implementing and maintaining the requirements of the quality management system.
The Beijing Municipal Drug Administration should continue to pay attention to the company’s production dynamics. If the enterprise resumes production, it shall improve the quality management system, conduct necessary verification and confirmation, and resume production only after passing the re-examination by the Beijing Municipal Drug Administration.