Summary： The Fujian Provincial Drug Administration released information on administrative penalties on the 25th. The information showed that Fujian Huoxin Sanitary Products Co., Ltd. was fined a total of 96500 yuan for producing substandard medical protective masks. The screenshot of the punishment information is as follows:

The Fujian Provincial Drug Administration released information on administrative penalties on the 25th. The information showed that Fujian Huoxin Sanitary Products Co., Ltd. was fined a total of 96500 yuan for producing substandard medical protective masks. The screenshot of the punishment information is as follows:

The summary of the content of the administrative penalty decision is as follows:

According to Nanchang Municipal Market Supervision and Administration Bureau's "Medical Device Supervision and Sampling Verification Letter" (Hong Shi Jian Xie Han [2023] No. 45) and "Inspection and Testing Report" (No.: YQCY20230023-NC, Inspection Category: Supervision and Sampling), the medical protective mask (specification: sterile folding ear hanging type-medium, batch number: 20221106) produced by the party concerned is unqualified, and the specific unqualified item is adhesiveness. On September 18, 2023, our bureau directly served the above-mentioned "Inspection and Testing Report" to the parties and conducted on-site verification. On September 28, Nanchang market supervision and Administration Bureau agreed to the parties to review the application. On November 9, our bureau received the inspection report of Fujian food and drug quality inspection institute (no 2023YC0843, re-inspection), and the re-inspection conclusion was still unqualified. On November 15, our bureau filed a case against the parties. On December 26, 2023 and January 2, 2024, our bureau conducted inquiries and investigations on two related personnel including Jiao *, the legal representative of the parties, and Wu *, the actual controller. Due to the complexity of the case, our bureau postponed the decision to handle the case until March 14, 2024.

On December 29, 2023, our bureau implemented administrative compulsory measures for seizure of 3600 medical protective masks recalled by the parties involved in the case with batch number 20221106 and quantity, and lifted the administrative compulsory measures on January 26, 2024.

According to the inquiry and investigation of the parties and related personnel and the analysis of the corresponding evidence materials, our bureau has determined the illegal facts of the parties. After investigation, the parties involved in the case produced a batch of 20221106 medical protective masks (specifications: large) from November 7 to 22, 2022, and the number of finished products was 30750. On November 28, 2022, the parties sold 30000 medical protective masks to Jiangxi Zhuchang Medical Devices Co., Ltd. without invoicing. As of October 19, 2023, the number of recalled tablets was 3600 and the number of unrecalled tablets was 27150, and no refund was made. The remaining 750 pieces were received by Wu * and used by employees of another enterprise in which he participated. No payment was made and no illegal income was generated. In summary, according to the "sales contract" of the parties involved, the price of the batch of medical protective masks involved is calculated at 0.4 yuan/piece, the total value of the batch of products involved is 12300 yuan, and the illegal income is 12000 yuan.

In addition, our bureau also found that the party had two batches of medical protective masks with batch numbers of 20221106 and 20221215, which were inconsistent with the registered contents. Among them, 96000 pieces of products with batch number of 20221215 were not sold. The medical protective mask instructions of the above two batches of products are inconsistent with the registered contents, which does not involve the quality problems of the main body of the products, and it is impossible to determine that they have illegal income.

The above facts are mainly proved by the following evidence:

1. Nanchang Municipal Market Supervision and Administration Bureau "Medical Device Supervision and Sampling Inspection Verification Letter" (Hong Shi Jian Xie Han No. 2023 No. 45), "Assistance in Investigation Letter" (Min Yao Jian Xia Ji Ban Han No. 2023 No. 71), "Reply Letter on Request for Assistance in Investigation of Matters Related to Medical Protective Masks" (Hong Shi Jian Jin Xie Han No. 2023 No. 73), "Assistance in Investigation of Suspected Production of Fujian Huo Xin Sanitary Products Co., Ltd. Letter on Sales of Products Involved in Cases of Medical Protective Masks Conformed to Compulsory National Standards (No. 2024 No. 7, Fujian Pharmaceutical Supervision Bureau) Reply on Sales of Products Involved in Cases of Medical Protective Masks Suspected by Fujian Huoxin Hygienic Products Co., Ltd. (No. 2024 No. 06, Hongshi Supervision Bureau) Acceptance Notice on Sampling and Re-inspection of Medical Devices, inspection and Testing Report of Jiangxi Medical Device Testing Center (YQCY20230023-NC), Inspection Report of Fujian Food and Drug Quality Inspection Institute (2023YC0843), explain the source of illegal clues, re-inspection and reply to the investigation;

2. The party's "business license", "medical device production license" (Fujian food and drug supervision equipment production Xu 20210760), medical protective masks "medical device registration certificate" (Fujian machinery note quasi -20222140131), to prove the party obtained the qualification of medical protective masks;

3. The party's "employee roster", Wu *, Wu *, Jiao *, Shen * and other four copies of the ID card each, to prove the identity and position of the relevant personnel of the party;

4. One copy of the materials submitted by the party concerned during the registration of medical protective masks, indicating the information submitted during the registration;

5. One copy of the "Instruction Manual" of the current version of the party's medical protective mask, one copy of the "Business License" of Fujian Huaguan Science and Technology Co., Ltd., and three original copies of the "Instruction Manual" of the medical protective mask extracted from the party's raw material warehouse and Fu Jianhua Tuan Science and Technology Co., Ltd. during on-site verification, explain the current use of medical protective masks version of the "instructions" and the actual use of the "instructions" and explain the relationship between Fujian Huituan Technology Co., Ltd. and Jiao;

6. The parties' medical protective masks "Production Operation Instructions", "Finished Product Inspection Procedures", "Finished Product Inspection Records", "Sterile and Ethylene Oxide Residue Inspection Records", "Inspection Equipment Ledger" and "Catalogue of Main Production Equipment and Inspection Equipment" prove the inspection procedures and process flow of the products involved;

7. The "Batch Production Record" of the medical protective mask (batch number: 20221106) and the "Purchase Contract" and "Certificate" of the ear band signed with Xiamen Fuji Sheng Packaging Technology Co., Ltd., indicating the production of the batch of products and the purchase and material of the ear band;

8. One copy of the "Sales Account", "Delivery Form", "Sales Contract" and "Mask Recordings" of the medical protective mask (batch number: 20221106) of the party concerned, one copy of the "Cargo Card" of the 20221106 medical protective mask with batch number, and one copy of Deng * work certificate of the sales staff of Jiangxi Zhuchang Medical Devices Co., Ltd., explaining the sales and price of the batch of products involved;

9. Jiangxi Zhuchang Medical Devices Co., Ltd. "Business License", "Medical Devices Business License" (No. 20182400 of Jiangxi Food and Drug Administration), "Class II Medical Devices Business Record Certificate" (No. 20182452 of Jiangxi Food and Drug Administration) and other materials each copy to prove the qualification of the purchaser;

10. One original copy of the party concerned's "Letter of Commitment for Taking Measures for Sampling Inspection of Unqualified Products", "Letter of Commitment for Taking Risk Control Measures and Re-inspection Notification", "Report on Cause Analysis and Corrective Measures for Sampling Inspection of Unqualified Products", "Release of Information on Active Recall of Medical Devices", "Report on Implementation of Recall Plan", "Letter of Commitment for Isolation and Control of Recall Products" and, 2 photos of the recalled products at the scene, indicating the risk control measures and recall of the batches involved;

11. One original of the party concerned, such as "Statement on Self-examination of Inconsistency between Medical Mask Instructions and Registered Relevant Contents" and "Report on Preparation, Use and Correction of Medical Protective Mask Instructions", etc., explaining the self-examination of other batches of medical protective mask instructions and the preparation, use and correction of Medical Protective Mask Instructions;

12. Inquire about 2 pictures of administrative punishment information of the parties in the national enterprise credit publicity system and credit China, indicating the past administrative punishment of the parties;

13. Two original copies of the "On-site Record" (time: August 29, 2023, December 29, 2023), decision on the implementation of administrative compulsory measures, decision on the lifting of administrative compulsory measures, proving on-site verification, implementation of seizure and lifting, etc;

14. The "Inquiry Record" of Jiao *, Wu * and others (time: December 26, 2023, January 2, 2024) explains the investigation and inquiry.

Based on the above facts, our bureau determined that the parties violated the provisions of Article 7 and Article 39 Paragraph 1 of the Regulations on the Supervision and Administration of Medical Devices, which respectively constituted the production of medical protective masks and medical protective masks that did not meet the mandatory national standards. The content of the mask instructions is inconsistent with the registered relevant content of the illegal act.

On March 5, 2024, our bureau directly served the "Notice of Administrative Punishment" (No. 3-07, 2023) on the parties concerned, informing the parties of the contents of the administrative punishment to be made, as well as the facts, reasons and basis, and informing them that they have the right to state, defend and request a hearing in accordance with the law. Within the statutory time limit, the parties did not submit a statement, defense and hearing request to our bureau.

In view of the fact that the parties actively cooperated with the investigation of the case and violated the law for the first time, in line with the provisions of Article 13, Item 1 and Article 14, Item 4 of the Detailed Rules for the Application of Administrative Penalty Discretion for Drug Supervision in Fujian Province (for Trial Implementation), it was decided that the illegal act of the parties producing medical protective masks that did not meet the mandatory national standards should be punished at a lighter punishment level, that the value of 5 times of 12300 yuan, that is, a fine of 61500 yuan.

In addition to the aforementioned light cases, the inconsistency between the contents of the instructions of the medical protective masks produced by the parties and the registered relevant contents, there are also cases of minor illegal acts and less social harm, which are in line with the provisions of items 1 and 2 of Article 13, item 4 of Article 14 and item 6 of paragraph 1 of Article 15 of the detailed rules for the application of administrative penalties for drug supervision in Fujian Province (for trial implementation). You can be given a lighter punishment. However, the parties found that they had used instructions that were inconsistent with the registered contents in the production process but did not correct them in time. They still examined and released them and sold them, and there was a situation of knowingly committing heavier administrative penalties. To sum up, the parties concerned meet the above-mentioned circumstances of both light and heavy, and decided to impose a fine of 23000 yuan according to the general penalty level.

In accordance with the second paragraph of Article 28 of the Administrative Punishment Law, the first paragraph of Article 86 of the Regulations on the Supervision and Administration of Medical Devices, and the Implementation Rules for the Application of Administrative Penalty Discretion for Drug Supervision in Fujian Province (for Trial Implementation) Article 13 Item 1 and Article 14 Item 4 decided to deal with the illegal acts of the parties producing medical protective masks that do not meet the mandatory national standards as follows:

(I) ordered to make corrections;

The (II) confiscated the illegal income of 12000 yuan (12,000 yuan);

(III) confiscation of the batch of 20221106 medical protective masks 3600;

(IV) fine of 61500 yuan (six thousand five hundred yuan).

In accordance with the provisions of Item 2 of Article 88 of the Regulations on the Supervision and Administration of Medical Devices and the Implementation Rules for the Application of Administrative Penalty Discretion for Drug Supervision in Fujian Province (for Trial Implementation), Items 1 and 2 of Article 13, Item 4 of Article 14 and Item 6 of Paragraph 1 of Article 15, the 2. decided to deal with the illegal acts of inconsistency between the instructions of the medical protective masks produced by the parties and the registered relevant contents as follows:

(I) ordered to make corrections;

(II) fine of 23000 yuan (23,000 yuan).

The total amount of the above fines is 96500 yuan (96,600 yuan).

The party concerned shall pay the above-mentioned fine within 15 days from the date of receiving this administrative penalty decision. According to the notice of payment for administrative penalty issued by Xiamen Drug Inspection Office of our bureau, the parties concerned choose the payment method by themselves. If the fine is not paid within the time limit, in accordance with the provisions of Article 72 of the Administrative Punishment Law, our bureau will impose a fine of 3% of the amount of the fine every day, and apply to the people's court for enforcement in accordance with the law.

If the party concerned does not accept this administrative penalty decision, he may apply to the Fujian Provincial People's Government for administrative reconsideration within 60 days from the date of receipt of this administrative penalty decision, or may file an administrative lawsuit with the People's Court of Gulou District, Fuzhou City within six months. During the period of applying for administrative reconsideration or filing an administrative lawsuit, the execution of the administrative penalty shall not be suspended.