Shaanxi Province will implement credit rating for health care products manufacturers ABCD four grades

On August 22, it was learned from the Provincial Food and Drug Administration that starting from September 9 this year, Shaanxi Province will implement credit rating and classification supervision and management for health care products manufacturers.

According to the Provincial Food and Drug Administration issued the “Measures for the Supervision and Management of Credit Rating and Classification of Shaanxi Health Care Products Manufacturing Enterprises (Trial)” (hereinafter referred to as “Measures”), the credit information of health care products manufacturing enterprises includes: Basic information, administrative licensing information, supervision and inspection information, product sampling information, complaint reporting information, and administrative penalty information.

The “Measures” clarify that the credit grades of health care products manufacturers in Shaanxi Province are classified into A (trustworthy), B (basic trustworthy), C (untrustworthy), and D (seriously untrustworthy). If one of the following conditions occurs in a health care product manufacturing enterprise, it shall be directly assessed as Class D, and its credit rating shall not be adjusted within two years: the product is detected illegally added, the doping is false; the administrative penalty imposed by the revocation permit; Those who have been ordered to suspend production or suspend business due to violations of relevant laws and regulations, or have been sentenced to more than three administrative penalties for fines within one year; illegally producing and operating health care products constitute a crime and are investigated for criminal responsibility according to law; The occurrence of a safety responsibility accident has caused adverse effects; serious violations of health supplies laws and regulations. The Provincial Food and Drug Administration will include production enterprises with a credit rating of D in the “blacklist” to facilitate joint disciplinary action by relevant departments.

The “Measures” stipulate that the food and drug supervision department shall carry out supervision and management according to the annual credit rating of health care product manufacturing enterprises. Among them, the A-level enterprise conducts at least one daily inspection every year; the B-level enterprise conducts at least one or two daily inspections every year; and the C-level enterprise conducts at least two to three daily inspections every year, for the legal representative and the enterprise The person in charge conducts an administrative interview. After being rectified by the D-class enterprises that have been ordered to suspend production and cease business, the municipal food and drug supervision department will conduct on-site inspections in accordance with relevant requirements. If the requirements are met, the county (city, district) food and drug supervision departments shall conduct at least 3 to 4 inspections per year. Listed as the main sampling object, the company is included in the flight check list. In combination with product safety risks, the county (city, district) food and drug regulatory authorities may increase the number of inspections and the number of inspections.