Supervisory administration of medicines and chemical reagents of Heibei province food executes the law writ
Administrative punishment decides a book
(Shi Yu feeds medical inspect) punish all right definitely 〔 2018 〕 011
Party: Shijiazhuang is restful hospital limited company
Address: Shijiazhuang city makes rich road of abundant of China area storehouse 48
Postcode: 050000
Integrate social credence code: 91130100795469901W
Contact means: 13932183683
Legal representative: Male post of Wu Weihai sexual distinction: Chief
Illegal fact:
On August 22, 2018, shijiazhuang city makes rich medicines and chemical reagents of China area food supervises management board to execute the law personnel accepts office of safety of municipal government food (city feeds medical inspect bureau) information of food safety public feelings the 11st period (always the 131st period) , make rich to be located in Shijiazhuang city road of abundant of China area storehouse restful hospital limited company undertakes 48 Shijiazhuang examination, discover this hospital controlled input of patient pool XX to exceed period of efficacy at 10 o'clock in the morning on August 21 of nearly 5 months expire " fluid of inject of sodium chloride of medicine made of two or more ingredients " photograph a piece, the Shijiazhuang with patient pool Xx is restful hospital temporarily doctor's advice is only two pages.
My bureau executes the law personnel had comprehensive examination on August 24 to this hospital, discover this hospital surpassed limited company of trade of medical apparatus and instruments to purchase at was being amounted to from Shijiazhuang on August 22 mix by Guangzhou can limited company of biology science and technology produces without serum lymphocyte education radical diagnoses reagent, in all 8 (240 bottles) , norms: 5ml/ bottle, lot number: SF20180516, register card number: 20140137, make clear in the manual of this reagent and label designation made clear keep in storage to ask to be: - the following keep in storage of 15 ° C, shijiazhuang city is restful hospital general among them 7 keep in storage come of this courtyard examine of division reagent freezer refrigerant inside, refrigerant the temperature between is: - 20 ° C comes - 23 ° C, this courtyard is gotten to go to the lavatory will among them one (30 bottles) keep in storage comes inside the springhouse of reagent freezer, the temperature of springhouse is: 4 ° C comes 10 ° C.
About evidence:
Investigation notes, sheet of the Id photocopy, business charter photocopy, product photograph, person of the same trade that follow money, spot notes, list of news of spot examination photograph, use record, public feelings, just reach manufacturing company for goods freezer of the cold chain record of relevant aptitude, reagent, reagent, the fact is clear, evidence is sufficient.
Punish basis and sort:
Because this hospital uses the medicines and chemical reagents in the process to sell stage Zhang in medicines and chemical reagents,record not complete, bring about this hospital to use overdue drug to the patient, disobeyed " Pharmaceutical Affairs Law of People's Republic of China " the 49th the first (3) " prohibit medicine of bad of production, sale. The content of component of medicines and chemical reagents does not accord with standard of national medicines and chemical reagents, for bad medicine. The drug that has one of following state, press bad drug decide on sb's punishment: (3) exceed period of efficacy; " regulation.
This hospital did not press medical apparatus and instruments of keep in storage of manual of product of medical apparatus and instruments and label designation requirement, disobeyed " service mass of medical apparatus and instruments supervises administrative measure " the 8th regulation: "Medical apparatus and instruments uses an unit to ought to produce management enterprise to purchase medical apparatus and instruments from the medical apparatus and instruments that has aptitude, ask for, check supplier aptitude, medical apparatus and instruments to register card to perhaps put on record the proof file such as the proof. To what purchase medical apparatus and instruments ought to identify product qualification to prove a file, undertake checking and accept by the regulation. Special to having store the medical apparatus and instruments that carry asks still ought to be checked store the requirement that carries whether the condition accords with product manual and label designation " . regulation.
When using government of medicines and chemical reagents to place in view of this hospital fulfill not strictly store the legal obligation that maintain, scanty at management, legal consciousness is thin, bring about the main reason of use bad medicine, put in subjective fault behavior. To make sure medicines and chemical reagents is safe, safeguard people is healthy with life safety. Use the act of bad medicine to party, according to " Pharmaceutical Affairs Law carries out byelaw " the 68th " medical establishment uses false medicine, bad drug, according to " Pharmaceutical Affairs Law " the 74th, the 75th regulation gives punishment. " according to " Pharmaceutical Affairs Law of People's Republic of China " the 74th " of medicine of bad of production, sale, the drug that confiscates illegal production, sale and illegal earning, be in money of drug of illegal production, sale to be worth amount one times above 3 times the following amerce; The clue is serious, instruct stop production, close down is rectified or cancel drug approval proves file, revoke " medicines and chemical reagents produces licence " , " business certificate of medicines and chemical reagents " or " licence of medical establishment preparation " ; Make crime, investigate criminal duty lawfully. Investigate criminal duty lawfully..
According to: " service mass of medical apparatus and instruments supervises administrative measure " the 28th " medical apparatus and instruments uses an unit to have one of following state, supervise management department by medicines and chemical reagents of food of prefectural class above according to " medical apparatus and instruments monitors regulation " the 67th regulation gives punishment " : "(one) did not ask according to manual of product of medical apparatus and instruments and label designation of medical apparatus and instruments of keep in storage " . " medical apparatus and instruments monitors regulation " the 67th " have one of following state, by medicines and chemical reagents of food of government of people of prefectural class above supervisory management department is instructed correct, be in 10 thousand yuan of above 30 thousand yuan of the following amerce; The clue is serious, order stop production stop business, till produce business certificate of licence, medical apparatus and instruments by medical apparatus and instruments of revoke of the former branch that send card " : "(3) did not ask to carry according to manual of medical apparatus and instruments and label designation, of medical apparatus and instruments of keep in storage " ; My bureau instructs your unit to did not press temperature keep in storage to return of the unit that offer money without serum lymphocyte education radical diagnoses reagent (30 bottles) .
My bureau on September 11, 2018 lawfully to your service " hearing of witnesses informs a book " [(Shi Yu feeds medical inspect) medicine of the inspect that feed medicine listens accuse 〔 2018 〕 036] . You did not offer opinion of allegation, averment and application of hearing of witnesses inside legal time limit.
My bureau decides to give the following administration punishment to you:
1, confiscate 6.44 yuan; 2, fine 15012.88 yuan.
Rise 15 days in the day that receives this punishment to decide a book please inside to subbranch of a bank of Heibei bank square north (account: Shijiazhuang city makes rich China area collects fees management board, zhang date: 62920120045450) pay is punished do not have a paragraph. Exceed the time limit is daily those who press amerce amount 3% increase condemnatory fund. Nonperformance of exceed the time limit punishs a decision, my bureau will apply for people court to be carried out compulsively.
If refuse to obey,punish a decision originally, can be in since the day that receives this condemnatory decision inside 60 days lawfully supervisory management board of medicines and chemical reagents of food of government of people of Xiang Yuhua division, Shijiazhuang city applies for administration to reconsider or 6 months introversion makes rich court of China division people is sued.
Shijiazhuang city makes rich medicines and chemical reagents of China area food controls management board
On September 17, 2018
