加拿大药监局的GMP检查状态跟踪（接受过国外GMP检查的工厂必看）

albertchen

附件是“加拿大药监局的GMP检查状态跟踪”，以下链接是即时更新的。附件是目前的状态（Last update: October 26, 2015）。
接受过加拿大、WHO、FDA和欧盟检查的工厂必看哦。


        

Establishment

      

Status   of Issue

   

Source   of Information under review

   

Primary   Reason for Action

  
   

Agila  Specialties Private Ltd., Specialty Formulation Facility (SFF) 19A, Plot No.  284-B/1 Bommasandra Jigani Link Road, Anekal Taluk, Bangalore India - 560 105

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Medically  necessary products identified

  

·          Requested  Voluntary Quarantine of non-medically necessary products

  

·          Regulatory  Partners

  

·          General  GMP observations

   

Apotex  Pharmachem India Private Limited (APIPL)
  Plot No. 1A, Bommasandra Industrial Area, 4th Phase, Jigani Link Road,  Bangalore, Karnataka, India

  

·          Requested  stop sale

  

·          Import  restrictions imposed

  

·          Issued  terms and conditions to Canadian importer(s)

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          HC  onsite (June 5-10) to verify implementation of corrective actions

  

·          Issued  terms and conditions to Canadian importer based on HC onsite corrective  actions inspection conducted on June 5-10

  

Related  recalls and alerts:

  

·          Health Canada puts measures in place for medically  necessary products affected by import restriction from 3 facilities in India

  

·          Apotex Product Recall (2015-04-10)

  

·          Expanded recall of Apo-Candesartan

  

·          Health Canada puts in place new oversight of Apotex  Inc. imports from APIPL and ARPL

  

·          Summary Report

  

·          Health  Canada

  

·          Regulatory  Partner

  

·          Data  integrity

  

·          General  GMP observations

   

Apotex  Research Private Limited (ARPL)
  Plot No. 1 and No. 2, Bommasandra Industrial Area, 4th Phase, Jigani Link  Road, Bangalore, India

  

·          Voluntary  quarantine was in place until further assessment was completed

  

·          Import  restrictions imposed

  

·          Issued  terms and conditions to Canadian importer(s)

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          HC  onsite (June 1-4) to verify implementation of corrective actions

  

·          Issued  terms and conditions to Canadian importer based on HC onsite corrective  actions inspection conducted on June 1-4

  

Related  recalls and alerts:

  

·          Health Canada requests quarantine of products for  Canadian market from Apotex facility in Bangalore, India

  

·          Health Canada puts measures in place for medically  necessary products affected by import restriction from 3 facilities in India

  

·          Apotex Product Recall (2015-04-10)

  

·          Expanded recall of Apo-Candesartan

  

·          Recall of Apo-Candesartan-HCTZ

  

·          Apo-Risperidone (2015-06-03)

  

·          Losartan-HCTZ (2015-06-03)

  

·          Health Canada puts in place new oversight of Apotex  Inc. imports from APIPL and ARPL

  

·          Summary Report

  

·          Health  Canada

  

·          Regulatory  Partner

  

·          Data  integrity

  

·          General  GMP observations

   

Cadila  Pharmaceuticals Limited.
  294, G.I.D.C. Industrial Estate, Ankleshwar, India

  

·          No  critical risks identified to date

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          No  medically necessary products identified at this time

  

·          Regulatory  Partner

  

·          General  GMP observations

   

Dr.  Reddy's Laboratories
  APIIC Ind. Est, Pydibhimavarma (Village) Ranasthalam Mandal, Srikakulam  District, India

  

·          Voluntary  quarantine in place

  

·          No  medically necessary products identified at this time

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

Related  recalls and alerts:

  

·          Health products quarantined from two sites in India as  Health Canada assesses data integrity concerns

  

·          Regulatory  Partner

  

·          Data  integrity

  

·          General  GMP observations

   

Emcure  Pharmaceuticals Limited
  Plot No. P-1 & P-2,, IT-BT Park Phase II, MIDC, Hinjwadi, Hinjwadi, Pune,  Maharashtra INDIA

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Continuing  to review evidence submitted (i.e. corrective actions, information from  regulatory partner)

  

·          Medically  necessary products identified

  

·          Regulatory  Partner

  

·          Canadian  importer(s)

  

·          General  GMP observations

  

·          Data  integrity

   

Everlight  Chemicals Industrial Corporation
  12, Industrial Third Rd, Kuanyin Industrial District, Kuanyin Hsiang, Taoyuan  Hsien, 32853, Taiwan

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          No  medically necessary products identified at this time

  

·          Non-Compliant  rating issued

  

·          Regulatory  Partners

  

·          Data  integrity

   

Hebei  Yuxing Bio-engineeering Co. Limited
  Xicheng District, Ningjin county, Ningjin, Heibei China

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          No  medically necessary products identified at this time

  

·          Requested  Voluntary Quarantine of non-medically necessary products

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partners

  

·          Data  integrity

   

Hospira  S.P.A
  Via Frosse Ardeatine 2 LIscate Italy

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Requested  voluntary quarantine

  

·          Medically  necessary products identified

  

·          Issued  terms and conditions to Canadian importer(s)

  

Related  recalls and alerts:

  

·          Health Canada restricts imports of drugs from Hospira  S.P.A, Italy due to data integrity concerns

  

·          Regulatory  Partner

  

·          Data  integrity

  

·          General  GMP observations

   

IPCA  Laboratories Ltd.
  P.O. Box No. 33 Village Sejavta Ratlam, Madya Pradesh, India

  

·          Voluntary  quarantine in place

  

·          Import  restrictions imposed

  

·          Issued  terms and conditions to Canadian importer(s)

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

Related  recalls and alerts:

  

·          Health Canada requests quarantine of products from IPCA  Laboratories following falsification and manipulation of data issues

  

·          Health Canada puts measures in place for medically necessary  products affected by import restriction from 3 facilities in India

  

·          Regulatory  Partner

  

·          Data  integrity

  

·          General  GMP observations

   

IPCA  Laboratories Ltd
  Plot 65 & 99, Dandudyog Industrial Estate, Piparia, Silvassa, Dadra &  Nagar Haveli (U.T.), 396 230, India

  

·          Terms  and conditions for IPCA Ratlam apply to the Piparia products

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partner

  

·          Data  integrity

  

·          General  GMP observations

   

IPCA
  1 Pharma Zone, SEZ Phase II, Sector 3, District Dhar, Pithampur, India

  

·          Voluntary  quarantine in place

  

·          No  medically necessary products identified at this time

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partner

  

·          Data  integrity

  

·          General  GMP observations

   

Megafine  Pharma (P) Limited
  48  - 51/201 Plot No 31 - 35 , Lakhamapur, Maharashtra India

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partner(s)

  

·          Data  Integrity

   

Micro  Labs Tamil Nadu
  92 Sipcot Industrial Complex
  Hosur - Tamil Nadu, India

  

·          Voluntary  quarantine in place while evidence is being reviewed

  

·          No  medically necessary products identified at this time

  

·          Import  restrictions imposed

  

·          Issued  terms and conditions to Canadian importer(s)

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner).

  

Related  recalls and alerts:

  

·          Health Canada takes action to restrict import of  products from three Micro Labs facilities in India

  

·          Regulatory  Partners

  

·          Data  integrity

  

·          General  GMP observations

   

Micro  Labs Goa
  Plot No. S-155 to S-159, Phase III,
  Verna Industrial Estate, Verna, India

  

·          Voluntary  quarantine in place

  

·          No  medically necessary products identified at this time

  

·          Import  restrictions imposed

  

·          Issued  terms and conditions to Canadian importer(s)

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

Related  recalls and alerts:

  

·          Health Canada takes action to restrict import of  products from three Micro Labs facilities in India

  

·          Regulatory  Partners

  

·          Data  integrity

  

·          General  GMP observations

   

Micro  Labs Bangalore
  Plots No. 113 to 116, 4th Phase, KIADB, Bommasandra Industrial Area, Jigani  Link Road, Anekal Taluk, Bangalore, India

  

·          Voluntary  quarantine in place

  

·          No  medically necessary products identified at this time

  

·          Import  restrictions imposed

  

·          Issued  terms and conditions to Canadian importer(s)

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

Related  recalls and alerts:

  

·          Health Canada takes action to restrict import of  products from three Micro Labs facilities in India

  

·          Regulatory  Partner

  

·          General  GMP observations

   

Minsheng  Group Shaoxing Pharmaceuticals Co.
  315  Tanggong Road, Paojiand Industrial Zone. Shaoxing, Zhejiang, China 312071

  

·          Requested  voluntary quarantine

  

·          Continuing  to review evidence submitted (i.e. corrective actions, information from  regulatory partner)

  

·          Medically  necessary products identified

  

·          Regulatory  Partner

  

·          Canadian  importer

  

·          Data  Integrity

  

·          General  GMP observations

   

Novacyl  (Thailand)
  321 Bangpoo Industrial Estate
  Praeska, Muang
  Sanutprakam, 10280
  Thailand

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          No  medically necessary products identified at this time

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          No  critical risks identified to date

  

·          Regulatory  Partner

  

·          General  GMP observations

   

Novacyl  Wuxi Pharmaceutical Co. Ltd.
  8 Guang Shi Xi Road, Wuxi, Jiangsu, 214185, China

  

·          No  critical risks identified to date

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          No  medically necessary products identified at this time

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partner

  

·          General  GMP observations

   

Sri  Krishna Pharmaceuticals Ltd
  UNIT II
  A-35, IDA Nacharam
  Hyderabad 500 076 India

  

·          Voluntary  quarantine in place

  

·          Issued  terms and conditions to Canadian importer(s)

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

Related  recalls and alerts:

  

·          Health products from Sri Krishna Pharmaceuticals  quarantined due to data integrity concerns

  

·          Release of medically necessary and non-medically  necessary products according to terms and conditions

  

·          Regulatory  Partners

  

·          Data  Integrity

  

·          General  GMP observations

   

Svizera  Laboratories Private Limited
  Plot D-16/6 TTC Industrial Area,
  MIDC
  Turbhe, Navi Mumbai, India

  

·          No  critical risks identified to date

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          No  medically necessary products identified at this time

  

·          Regulatory  Partner

  

·          Canadian  importer

  

·          Data  Integrity

  

·          General  GMP observations

   

Unimark  Remedies Limited
  337 Kerala Nalsarovar Road, Kerala Village, Bavla, Ahmedabad District 530  049, India

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partner(s)

  

·          Data  Integrity

   

Vuab  Pharma a.s
  Vltavska 53, Roztoky, Czech Republic

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partners

  

·          General  GMP observations

  

·          Data  Integrity

   

Zhejiang  Hisoar Pharmaceutical Co. Ltd.
  No. 100 Waisha Branch Rd, Jiaojiang, Taizhou City, Zhejiang Province CN

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          Requested  Voluntary Quarantine of non-medically necessary products

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Regulatory  Partners

  

·          Data  Integrity

   

Zhejiang  Hisun Pharma Company Ltd.
  46 Waisha Road,
  Jiaojiang District,Taizhou City,
  Zhejiang, China

  

·          Requested  voluntary quarantine

  

·          Continuing  to review evidence submitted (i.e corrective actions, information from  regulatory partner)

  

·          Medically  necessary products identified

  

Related  recalls and alerts:

  

·          Health Canada requests quarantine of products imported  for Canadian market from Zhejiang Hisun Pharma due to data integrity concerns

  

·          Regulatory  Partner

  

·          Canadian  importer

  

·          Data  Integrity

  

·          General  GMP observations

        

Closed   Items

     
     

Establishment

   

Status   of Issue

   

Source   of Information under review

   

Primary   Reason for Action

  
   

Agila  Onco Therapeutics Ltd. Plot No. 284/B Bommasandra Jigani Link  Road, Industrial Area, Bangalore, Kamataka, India

  

·          Non-compliant  rating issue

  

·          No  further action required by Health Canada at this time

  

·          Related  recalls and alerts:

  

·          Methotrexate Injection USP 50 mg/2 mL - Voluntary  Recall Due to the Potential Presence of Foreign Particulate Matter

  

·          Canadian  importer(s)

  

·          Regulatory  Partner(s)

  

·          General  GMP observations

   

Agila  Specialties Private Ltd. Opp II M, Bilekahalli, Bannerghatta Road,  Bangalore, Karnataka, India - 560 076

  

·          Canadian  importer(s) contacted by Health Canada for information

  

·          No  critical risks identified to date

  

·          No  further action required by Health Canada at this time

  

·          Regulatory  Partner(s)

  

·          General  GMP observations

   

Jinan  Jinda Pharmaceutical Chemistry Co. Ltd.
  No. 6121 Longquan Road Zhangqiu, Shandong Province 250 20, China

  

·          No  medically necessary products identified at this time.

  

·          Non-compliant  rating issued

  

·          No  further action required by Health Canada at this time

  

·          Regulatory  Partner(s)

  

·          Data  integrity

  

·          General  GMP observations

   

Mahendra  Chemicals
  B-1, 217, 218/2, G.I.D.C. Estate, Naroda Ahmedabad, Gujarat India

  

·          Canadian  importer(s) contacted by Health Canada for information.

  

·          No  medically necessary products identified

  

·          Non-Compliant  rating issued

  

·          No  further action required by Health Canada at this time

  

·          Regulatory  Partner(s)

  

·          Data  Integrity

   

Polydrug  Laboratories Pvt. Ltd.
  Plot no. 37, Anand Nagar, M.I.D.C., India - 421 506 Ambernath (East),  Maharashtra

  

·          No  medically necessary products identified at this time

  

·          Non-compliant  rating issued

  

·          No  further action required by Health Canada at this time
  Related recalls and alerts:

  

·          Health Canada requests quarantine of products imported  for Canadian market from Polydrug Laboratories due to data integrity concerns

  

·          Regulatory  Partner(s)

  

·          Data  Integrity

  

·          General  GMP observations

罗伊鲱

Inspection tracker: Drug manufacturing establishments

albertchen

还是需要顶！

frizyj

加拿大的审计缺陷没有具体信息，是吧。我找不到呀

叶非

frizyj 发表于 2015-11-4 08:34
加拿大的审计缺陷没有具体信息，是吧。我找不到呀

这个不是加拿大的审计信息，而是加拿大的药政，对进口到加拿大的企业的GMP状态的更新，比如说，是否接到过FDA的警告信。

叶非

albertchen 发表于 2015-11-4 06:20
还是需要顶！

帮你顶下！这个信息可以从侧面知道一个企业的认证状态，最早的时候，海正的检查失败，就是加拿大首先发出的进口警告。

xhf123456

学习一下

xqliu

学习一下啦，谢谢提供分享。

syhorchid

学习一下

albertchen

frizyj 发表于 2015-11-4 08:34
加拿大的审计缺陷没有具体信息，是吧。我找不到呀

加拿大的警戒，都是别国的GMP检查结果的衍生后果。

albertchen

uiofer 发表于 2015-11-4 08:41
帮你顶下！这个信息可以从侧面知道一个企业的认证状态，最早的时候，海正的检查失败，就是加拿大首先 ...

海翔和民生也是呀，10月26日发布的。
海正已是旧闻。
海正和海翔的检查官都是彼得·贝壳先生。

albertchen

顶起来！！

albertchen

再订

albertchen

新年快乐！

小金库

感谢楼主