ABSTRACT
As an important part of medical devices, in vitro diagnostic reagents are important means to prevent and diagnose and protect people's health. Supervision and sampling is an important and key supervision method to ensure the in vitro diagnostic reagent products are qualified. This paper summarizes the problems encountered in recent years in vitro diagnostic quantitative testing kit supervision sampling, analyzes the causes of these problems, and puts forward corresponding suggestions, hoping to provide constructive suggestions for supervision sampling.
Subject(s)
Humans , Hematologic Tests , Reagent Kits, Diagnostic , Reference StandardsABSTRACT
Objective:To describe the unqualified situation of infant formula food by supervision and sampling inspection in China， and then recommend appropriate countermeasures. Methods:The results of supervision and sampling inspection of infant formula food were summarized from 2015 through 2020 in China， and the unqualified items were classified and analyzed. Results:From 2015 through 2020， a total of 30 252 batches of infant formula food were sampled and examined in China， in which 187 batches were determined to be unqualified with an overall unqualified rate of 0.62% （187/30 252）. Content of items in 82 batches of samples did not meet the national standards for food safety， accounting for 43.85% （82/187） of the total number of unqualified batches. Labels in 105 batches were unqualified， accounting for 56.15% （105/187）. Generally， the unqualified rate of infant formula food showed an overall downward trend over years， with a 1.8% of decrease between 2020 （0.03%） and 2015 （1.83%）. The main problems in the unqualified infant formula food in China were minerals， vitamins， optional ingredients， microorganisms and conventional nutrients， which accounted for 39.50% （94/238）， 15.97% （38/238）， 14.29% （34/238）， 10.50% （25/238） and 10.08% （24/238） of the total unqualified items， respectively. Conclusion:Food manufacturers should strictly implement the principal responsibility of food safety， and government regulatory sectors should continue to strengthen the supervision to ensure the quality and safety of infant formula food.
ABSTRACT
Theories of classified management which are based on risk governance are introduced into the newly revised , but the punishments on the manufacturers of unconformity products are not classified based on the severity and risks caused by the test items. This article analysed the disadvantages of current punishment measures on the manufacturers of unconformity products and the theoretical basis of classified punishments. The feasibility of classified punishments had also been studied and some basis of discretionary punishments was provided under the current regulations.