# 521902585363
Unscheduled inspection
Start date: 2019-03-21, end date: 2019-04-17, duration: —
Authority: Territorialnyi organ Federalnoi sluzhby po nadzoru v sfere zdravoohraneniya po Nizhegorodskoi oblasti
Purpose of inspection: nastoyaschaya proverka provoditsya s celyu vyyasneniya obstoyatelstv svidetelstvuyuschih o vozniknovenii ugrozy prichineniya vreda zhizni zdorovyu grazhdan vyrazhayuschihsya v sleduyuschem realizaciya otpusk OOO «Erkafarm Nizhnii Novgorod» i vozmozhno nalichie v obraschenii v OOO «Erkafarm Nizhnii Novgorod» lekarstvennogo preparata «Famvir tabletki pokrytye obolochkoi 125 mg 10 sht upakovki yacheikovye konturnye 1 pachki kartonnye» seriya VT238 proizvodstva Novartis Farmasyutika SA Ispaniya proyavlenie nezhelatelnoi reakcii pri primenenii kotorogo obuslovilo somnenie v podlinnosti lekarstvennogo sredstva motivirovannoe predstavlenie o neobhodimosti provedeniya vneplanovoi proverki bn ot 14 marta 2019 g dolzhnostnogo lica Territorialnogo organa Federalnoi sluzhby po nadzoru v sfere zdravoohraneniya po Nizhegorodskoi oblasti po rezultatam rassmotreniya obraschenii grazhdanina Vh 09K1306 ot 26022019 Vh 09K1303 ot 26022019 Vh 09K1302 ot 01032019 zadachami nastoyaschei proverki yavlyayutsya kontrol za soblyudeniem Obschestvom s ogranichennoi otvetstvennostyu «Erkafarm Nizhnii Novgorod» licenzionnyh trebovanii pri osuschestvlenii farmacevticheskoi deyatelnosti trebovanii k hraneniyu otpusku realizacii lekarstvennogo preparata «Famvir tabletki pokrytye obolochkoi 125 mg 10 sht upakovki yacheikovye konturnye 1 pachki kartonnye» seriya VT238 proizvodstva Novartis Farmasyutika SA Ispaniya provedenie otbora obrazcov lekarstvennogo sredstva «Famvir tabletki pokrytye obolochkoi 125 mg 10 sht upakovki yacheikovye konturnye 1 pachki kartonnye» seriya VT238 proizvodstva Novartis Farmasyutika SA Ispaniya pri neobhodimosti v ramkah federalnogo gosudarstvennogo nadzora v sfere obrascheniya lekarstvennyh sredstv dlya ekspertizy ih kachestva na baze FGBU «IMCEUAOSMP» Roszdravnadzora Kurskii filial Predmetom nastoyaschei proverki yavlyaetsya soblyudenie obyazatelnyh trebovanii i ili trebovanii ustanovlennyh municipalnymi pravovymi aktami
# 331801970480
Unscheduled inspection
Start date: 2018-10-11, end date: 2018-10-11, duration: —
Authority: Departament zdravoohraneniya Vladimirskoi oblasti
Purpose of inspection: nastoyaschaya proverka provoditsya s celyu proverki polnoty i dostovernosti svedenii o licenziate soderzhaschihsya v predstavlennyh zayavlenii o pereoformlenii licenzii na osuschestvlenie farmacevticheskoi deyatelnosti LO3302001483 ot 11102018g i dokumentah
# 521800350748
Unscheduled inspection
Start date: 2018-04-26, end date: 2018-05-14, duration: —
Authority: Upravlenie Federalnoi sluzhby po nadzoru v sfere zaschity prav potrebitelei i blagopoluchiya cheloveka po Nizhegorodskoi oblasti
Purpose of inspection: implementation of control supervision over the fulfillment of mandatory requirements of the legislation of the Russian Federation in the field of ensuring sanitary and epidemiological welfare of the population
# 331800046568
Unscheduled inspection
Start date: 2018-01-24, end date: —, duration: —
Authority: —
Purpose of inspection:
# 331800049479
Unscheduled inspection
Start date: 2018-01-26, end date: 2018-02-15, duration: —
Authority: Departament zdravoohraneniya Vladimirskoi oblasti
Purpose of inspection: osuschestvlenie licenzionnogo kontrolya v otnoshenii licenziata predstavivshego zayavlenie o pereoformlenii licenzii na osuschestvlenie farmacevticheskoi deyatelnosti LO3302001393 ot 23012018 g
# 16170802991583
Unscheduled inspection
Start date: 2017-12-05, end date: —, duration: —
Authority: —
Purpose of inspection:
# 16170802958923
Unscheduled inspection
Start date: 2017-12-05, end date: 2017-12-05, duration: —
Authority: Ministerstvo zdravoohraneniya Respubliki Tatarstan
Purpose of inspection: This check is carried out in order to determine the availability of documents required by the legislation of the Russian Federation, the completeness and reliability of the information provided in the application and the documents attached to it, including information received by the Ministry of Health of the Republic of Tatarstan through interdepartmental information interaction to confirm the licensee's compliance with licensing requirements for pharmaceutical activities the task of this check is to verify the licensee's compliance with licensing requirements for pharmaceutical activities An on-site inspection is the condition of premises buildings structures technical means equipment and other facilities that are supposed to be used by the licensee in carrying out the licensed type of activity and the availability of employees necessary for carrying out the licensed type of activity in order to assess the compliance of such facilities and employees with licensing requirements