Listed at local level Shunde District food and Drug Administration

Measures for responsibility interview of food and drug production and marketing units of Guangdong food and Drug Administration through2016year11month8Deliberated and adopted at the executive meeting of the Bureau,It was examined and approved by the Legislative Affairs Office of the people's Government of Guangdong Province.It is hereby printed and distributed to you,Please follow.

enclosure

Guangdong food and Drug Administration

Measures for responsibility interview of production and business operation units

      Article 1 To promote food Containing health food drugs Cosmetics and medical devices Hereinafter referred to as food and drug Production and business operation entities shall implement the main responsibility of food and drug safety,Regulate the production and marketing of food and drugs,Improve management level,Effectively prevent and timely eliminate hidden dangers of food and drug safety,according to Food safety law of the people's Republic of China Drug Administration Law of the people's Republic of China Regulations on the supervision and administration of medical devices Regulations of Guangdong Province on food safety and Measures for flight inspection of drugs and medical devices And other laws and regulations,These measures are hereby formulated.

      Article 2 Responsibility interview as mentioned in these measures,It refers to the food and drug regulatory departments at all levels in our province Hereinafter referred to as the interview authority According to statutory duties,To standardize production and operation,For the purpose of eliminating potential food and drug safety hazards,Meet with relevant responsible personnel of food and drug production and marketing units,Guide the implementation of rectification,A cautionary talk to urge the full implementation of the main responsibility.

      Article 3 The responsibility interview object is the legal representative or main person in charge of the food and drug production and marketing unit.When necessary,The interview authority may require the quality director of the unit qualified person Food safety management personnel or other relevant personnel shall participate in the interview.The interviewee shall show valid identification before the interview.

      Article 4 The food and drug production and marketing entity is under any of the following circumstances:,The interview authority may conduct responsibility interviews

one Food and drug safety problems,May cause the spread of food and drug safety risks

two In daily supervision and inspection Flight inspection Tracking inspection Double random During the random inspection, it is found that there are potential food and drug safety hazards in food and drug production and trading units,Failure to take timely measures to eliminate

three The applicant is suspected of concealing the true situation or providing false materials to apply for permission,Or the production and operation conditions shall be changed according to law Filing without actively applying for change Filed  

four Supervision and sampling inspection Check Or the product is found to have major potential food and drug safety hazards through risk monitoring

five Publishing serious illegal advertisements or exaggerating false publicity to deceive consumers

six Failing to rectify the existing food and drug safety problems in accordance with the requirements of the regulatory authorities,Or failing to recall unsafe products in accordance with relevant regulations

seven Food and drug safety problems that have been complained and reported for many times and verified to be true or have not been properly handled in a timely manner,Potential food and drug safety hazards

eight Other circumstances under which the food and drug regulatory authorities consider it necessary to conduct responsibility interviews.

The responsibility interview shall not affect the administrative treatment of the food and drug regulatory department according to law.

      Article 5 Main contents of responsibility interview

one Publicize relevant laws and regulations on food and drug supervision,Make it clear that the food and drug production and marketing units are responsible for the safety of their food and drug production and marketing,Clarify the responsibilities and requirements of the legal representative as the first person responsible for food and drug safety

two Notify the existing problems of food and drug production and marketing units Violations or potential risks,Find and analyze the causes and possible hazards of the problems,Specific contents and measures for guiding rectification,Determine the rectification period

three Listen to the measures taken by the unit to implement the main responsibility,Ask about quality management status,Understand the implementation of relevant laws and regulations,Rectification of problems found during exchange supervision,Listen to statements and commitments

four Further strengthen the management of the unit in the future Put forward requirements and guidance for controlling food and drug safety risks

five Other contents to be interviewed.

      Article 6 Responsibility interview procedure

one The food and drug production and marketing entity has one of the responsibility interviews specified in Article 4 of these measures,The food and drug regulatory departments at all levels shall propose responsibility interviews according to their respective jurisdiction and responsibilities,with Notice on responsibility interview of food and drug production and marketing units in Guangdong Province enclosure1 Notify the interviewed enterprise in advance.When necessary,The food and drug regulatory department at a higher level may require the food and drug regulatory department at a lower level to interview the food and drug production and marketing unit.

two In principle, the responsibility interview shall be conducted by the leader in charge of the food and drug regulatory department or entrusted by the food and drug regulatory office section thigh Implemented by the person in charge of the Office Involving major events or there may be serious potential food and drug safety hazards,Interview shall be conducted by the main person in charge of the food and drug regulatory department.

three According to responsibilities and work needs,Regulations can be invited during the interview Inspection and other supervision division section thigh Room personnel participation,News media can also be invited as needed Consumer representatives and relevant technical experts participated in the interview.

four During the interview,At least2Supervisors were present,It shall be filled in by a specially assigned person Responsibility interview records of food and drug production and operation units in Guangdong Province enclosure2 .At the end,The interview record shall be signed and confirmed by both parties.The interviewee refuses to sign,It should be noted in the interview record,It shall be signed and confirmed by other witnesses on site.If necessary, the interview records can be formed into interview minutes and sent to relevant units.

five The interviewed unit disagrees with the interview content,Have the right to make statements or defend Facts presented Justifiable,The interview organ shall record truthfully.

      Article 7 The interviewed unit cannot participate in the responsibility interview on schedule due to special reasons,Should be in advance1Report in writing to the interviewing authority within working days and explain the reasons,The interview time shall be re determined with the consent of the interview authority.

      Article 8 The interviewed unit shall meet the requirements,Comprehensively rectify the problems pointed out in the responsibility interview,The rectification shall be reported in writing to the food and drug regulatory department at the county level where the interview authority and the unit are located within the specified time limit.

      Article 9 After the interview,The interview authority can organize the follow-up inspection of the interviewed unit after the rectification period,Conduct on-site verification on the rectification of the problems raised in the responsibility interview.

The interviewee refuses to participate in the responsibility interview without justified reasons or fails to implement rectification as required,The food and drug regulatory authorities shall increase the frequency of supervision and inspection,Their illegal acts shall be strictly investigated and punished according to law.The situation is serious,Inform relevant departments to take joint disciplinary measures in accordance with relevant regulations.

      Article 10 The interview authority shall notify the responsibility interview in time Interview records, rectification report and other relevant materials shall be sorted out in a centralized manner,Incorporated into the unit's credit file according to law.

      Article 11 Market launch Administration square Third party platform provider for online food and drug trading Food and drug storage transport service provider Responsibility interview of food and drug research institutions and drug clinical trial institutions,It shall be implemented with reference to these measures.

      Article 12 These measures are from2017year2month1Effective as of,Valid for five years.