# 001700434556
Unscheduled inspection
Start date: 2017-09-07, end date: 2017-09-07, duration: —
Authority: Mezhregionalnoe upravlenie Federalnoi sluzhby po regulirovaniyu alkogolnogo rynka po Sibirskomu federalnomu okrugu
Purpose of inspection: The purpose of monitoring the implementation of the order of the Federal Service for Alcohol Market Regulation dated 22062017 115020102, hereinafter referred to as the Order expired 25082017. The purpose of this audit is to establish the fact that Shaklin LLC has not eliminated violations of the terms of the license for the purchase, storage and supply of alcohol-containing non-food products identified during the audit of the organization act dated 13012017 u6a2102, hereinafter referred to as the Act of the Ministry of Alcohol Regulation in the Siberian Federal District, as specified in the Regulation, namely, to eliminate violations of paragraph 2 of the Requirements for technical means of recording and transmitting information on the volume of production and turnover of alcoholic beverages to the unified state automated information system for accounting for the volume of production and turnover of ethyl alcohol, alcoholic and alcohol-containing products approved by Decree of the Government of the Russian Federation dated 09072016 650 to eliminate violations of the requirements for filling out declarations on the volume of production, turnover and or use of ethyl alcohol of alcoholic and alcohol-containing products on the use of production capacities, hereinafter referred to as the declaration approved by the order of the Federal Alcohol Regulatory Agency dated 23082012 231, namely, to submit corrective declarations, The subject of this audit is the measures taken by Shaklin LLC to comply with the Regulation
# 542100089496
Unscheduled inspection
Start date: 2021-03-24, end date: —, duration: 20
Authority: Territorialnyi organ Federalnoi sluzhby po nadzoru v sfere zdravoohraneniya po Novosibirskoi oblasti
Purpose of inspection: purpose: to implement the control and supervisory powers of the Territorial Body of Roszdravnadzor in the Novosibirsk Region in accordance with the Regulations on the Territorial Body of the Federal Service for Healthcare Supervision, approved by Order of the Ministry of Health of the Russian Federation dated 08/13/2020 No. 844n, in connection with the receipt of instructions from the Federal Service for Healthcare Supervision dated 12/22/2020 No. 04-76023/20 on sampling of medical products. The basis is the results of the examination of quality, effectiveness and safety, which contain the conclusion that there is a threat of harm to the health of citizens when using a medical "Disposable sterile syringe with a needle (23G x 1") 0.6 x 25 mm 2 ml, type 4", production date 10062019, manufactured by "Branding Forners Medical Equipment Co., Ltd", China, registration certificate No. FSZ 2011/09587 dated 05.09.2011, unlimited validity period, LOT 100619 and others for assessing the consistency of the identified violations and based on a reasoned idea of the need for an unscheduled on-site inspection dated 17.02.2021 №03-39-07/21.
The objectives of this review are:
- verification of compliance by subjects of medical device circulation with the rules in the field of medical device circulation,
- verification of compliance with the requirements of regulatory, technical and operational documentation of medical devices;
- verification of compliance of medical products in circulation with the established quality requirements;
- sampling of a medical device "Disposable sterile syringe with needle (23G x 1") 0.6 x 25 mm 2 ml, type 4", production date 10062019, manufactured by "Branding Forners Medical Equipment Co., Ltd.", China, registration certificate dated 05.09.2011 №FSZ 2011/09587, validity unlimited, LOT 100619 and other to assess the consistency of the identified violations for the examination of quality, effectiveness and safety.
# 542004428808
Unscheduled inspection
Start date: 2020-06-09, end date: 2020-07-09, duration: —
Authority: Territorialnyi organ Federalnoi sluzhby po nadzoru v sfere zdravoohraneniya po Novosibirskoi oblasti
Purpose of inspection: the purpose of implementing the supervisory powers of the Territorial Body of Roszdravnadzor in the Novosibirsk region in accordance with the Regulations on the territorial Body of the Federal Service for Healthcare Supervision approved by Order of the Ministry of Health of the Russian Federation dated 13122012 1040n in connection with the receipt of instructions from the Federal Service for Healthcare Supervision dated 01062020 102886820 on the selection of samples of medical products The basis of the results of the examination of the quality of effectiveness and safety, which contain the conclusion that there is a threat of harm to the health of citizens when using a medical device and based on a reasoned idea of the need for an unscheduled on-site inspection from 03062020 03390720the tasks of this inspection are to verify compliance by subjects of medical device circulation with the rules in the field of medical device circulation, to verify compliance with the requirements of regulatory technical and operational documentation of medical devices, to verify the conformity of medical devices The purpose of this review is to note the necessary compliance with the mandatory requirements and or requirements established by municipal legal acts and the implementation of measures to prevent the threat of harm to the life and health of citizens.
# 001700434556
Unscheduled inspection
Start date: 2017-09-07, end date: 2017-09-07, duration: —
Authority: Mezhregionalnoe upravlenie Federalnoi sluzhby po regulirovaniyu alkogolnogo rynka po Sibirskomu federalnomu okrugu
Purpose of inspection: The purpose of monitoring the implementation of the order of the Federal Service for Alcohol Market Regulation dated 22062017 115020102, hereinafter referred to as the Order expired 25082017. The purpose of this audit is to establish the fact that Shaklin LLC has not eliminated violations of the terms of the license for the purchase, storage and supply of alcohol-containing non-food products identified during the audit of the organization act dated 13012017 u6a2102, hereinafter referred to as the Act of the Ministry of Alcohol Regulation in the Siberian Federal District, as specified in the Regulation, namely, to eliminate violations of paragraph 2 of the Requirements for technical means of recording and transmitting information on the volume of production and turnover of alcoholic beverages to the unified state automated information system for accounting for the volume of production and turnover of ethyl alcohol, alcoholic and alcohol-containing products approved by Decree of the Government of the Russian Federation dated 09072016 650 to eliminate violations of the requirements for filling out declarations on the volume of production, turnover and or use of ethyl alcohol of alcoholic and alcohol-containing products on the use of production capacities, hereinafter referred to as the declaration approved by the order of the Federal Alcohol Regulatory Agency dated 23082012 231, namely, to submit corrective declarations, The subject of this audit is the measures taken by Shaklin LLC to comply with the Regulation