InSpec

Main information

  • Trade name:
  • InSpec Ox
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • InSpec Ox
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 211513
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

211513

MMRC Pty Ltd, Hospital Grade Disinfectants, with Non-Specific Claims, Hydrogen peroxide/Peracetic acid,

Non-sterile

ARTG entry for

Other Therapeutic Good - Listed disinfectant

Sponsor

MMRC Pty Ltd

Postal Address

PO Box 4,ASHBURTON, VIC, 3147

Australia

ARTG Start Date

27/06/2013

Product category

Other Therapeutic Good

Status

Active

Approval area

Medical Devices

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. InSpec Ox

Product Type

Single Device Product

Effective date

27/06/2013

GMDN

9950 Disinfectant, hospital grade

Intended purpose

A pre-diluted 0.2 micron filtered into sterile packaging liquid disinfectant designed for cleanroom walls,

floors ceilings and work surfaces. This solution is pre-diluted, do not

dilute. Hold bottle in the upright position. Spray from about 15cm ensuring total cover, leave for appropriate

wet contact time.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 11.11.2017 at 07:47:07 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

9-11-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs

Statement from FDA Commissioner Scott Gottlieb, M.D., on new steps to strengthen and modernize agency’s oversight and reporting of inspections for sterile injectable drugs

FDA is taking steps to modernize the agency’s inspections program

FDA - U.S. Food and Drug Administration

7-11-2018

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh Incorporation Issues Voluntary Nationwide Recall of Puriton Eye Relief Drops Due to Non-Sterile Production Conditions

Kadesh, Inc. of Garden Grove, CA is voluntarily recalling all lots of Puriton Eye Relief Drops, 0.5 oz. (15ml) bottle, UPC 7 36972 1679 0, to the consumer level. During a recent FDA inspection, investigators observed that ophthalmic drugs, which are required to be sterile, are manufactured without necessary production controls and conditions to assure sterility.

FDA - U.S. Food and Drug Administration

1-11-2018

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Information required for dossiers to support demands for import of high risk plants, plant products and other objects as foreseen in Article 42 of Regulation (EU) 2016/2031

Published on: Wed, 31 Oct 2018 00:00:00 +0100 Article 42 of the new Plant Health Law (Regulation (EU) 2016/2031 on protective measures against pests of plants), introduce a concept of “high risk plants, plant products and other objects” in relation to the presence of a pest risk of an unacceptable level for the Union territory, identified on the basis of a preliminary assessment to be followed by a risk assessment. Upon request of the European Commission (EC), the European Food Safety Authority (EFSA) d...

Europe - EFSA - European Food Safety Authority Publications

11-9-2018

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance

Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

5-9-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s global efforts to help assure product quality and transparency at foreign drug manufacturing facilities

FDA is publishing its internal policy for how manufacturing facilities are prioritized and scheduled for surveillance inspections in an effort to ensure the quality and safety of globally produced products.

FDA - U.S. Food and Drug Administration

10-8-2018

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Levothyroxine and Liothyronine (Thyroid Tablets, USP) Due to Risk of Adulteration

Westminster Pharmaceuticals, LLC is voluntarily recalling all lots, within expiry, of Levothyroxine and Liothyronine (Thyroid Tablets, USP) 15 mg, 30 mg, 60 mg, 90 mg, & 120 mg to the wholesale level. These products are being recalled as a precaution because they were manufactured using active pharmaceutical ingredients that were sourced prior to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd., which as a result of a 2017 inspection were found to have deficiencies with Current Good Ma...

FDA - U.S. Food and Drug Administration

28-7-2018

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory Issues Voluntary Recall of All Sterile Compounded Products Within Expiry Due to Lack of Sterility Concerns

Ranier’s Rx Laboratory is voluntarily recalling all sterile compounded drug products within expiry to the hospital or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

FDA - U.S. Food and Drug Administration

21-7-2018

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio Issues Voluntary Nationwide Recall of Aquaflora Candida HP9, Lymph Detox, and Baby Teething Liquids Due to Microbial Contamination

King Bio is voluntarily recalling four lots of Aquaflora Candida HP9, Lymph Detox, and Baby Teething liquids to the consumer level. During a routine inspection by the U.S. Food and Drug Administration, the products were found to contain microbial contaminants Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans.

FDA - U.S. Food and Drug Administration

20-7-2018

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Camco Manufacturing, Inc. recalls Camco RV Awning Water Proofer

Health Canada's inspection program found the recalled product does not meet the labelling and child-resistant packaging requirements for consumer chemical products as set out in the Consumer Chemicals and Containers Regulations, 2001.

Health Canada

28-6-2018

Clinical Investigator Inspection List (CLIIL)

Clinical Investigator Inspection List (CLIIL)

The Clinical Investigator Inspection List contains names, addresses, and other pertinent information gathered from inspections of clinical investigators who have performed studies with investigational new drugs.

FDA - U.S. Food and Drug Administration

8-5-2018

New Tariff for fees collected by the Icelandic
Medicines Agency

New Tariff for fees collected by the Icelandic Medicines Agency

Tariff No 404/2018 for marketing authorisations, annual fees and other licence fees for medicinal products and other related products, collected by the Icelandic Medicines Agency, was published in the Official Journal on 25th of april 2018 and came into force on the 7th of May 2018.TARIFF No 545/2017 for inspections and registration regarding medical devices remains the same. 

IMA - Icelandic Medicines Agency

28-3-2018

DKMA Update March 2018

DKMA Update March 2018

In this issue of DKMA Update you can read about evidence; changes to Tramadol’s summary of product characteristics; inspections of the sale of OTC medicines outside pharmacies and much more

Danish Medicines Agency

23-1-2018

Overview of changes requiring an inspection in the GMP area

Overview of changes requiring an inspection in the GMP area

Companies that manufacture medicines must be authorised to perform manufacturing activities by the Danish Medicines Agency according to section 39 of the Danish Medicines Act. They must comply with the rules on good manufacturing practice (GMP) and will be inspected regularly by our GMP inspectors.

Danish Medicines Agency

8-9-2017

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector in its Inspection Unit

The Icelandic Medicines Agency advertises a vacancy for an inspector. The Agency is looking for a candidate who is willing and able to work on demanding and interesting tasks, including travels in Iceland and abroad on behalf of the Agency. The vacancy is a full post (100%).

IMA - Icelandic Medicines Agency

26-5-2017

Malta and Iceland strengthen cooperation on medicines regulation

Malta and Iceland strengthen cooperation on medicines regulation

The Malta Medicines Authority made a cooperation agreement with the Icelandic Medicines Agency in an effort to strengthen capacity for medicines authorisations through joint assessment.  The agreement will facilitate mutual training for experts and explore the feasibility of conducting joint inspections.

IMA - Icelandic Medicines Agency

13-3-2017

EuropharmaDK regains its authorisation

EuropharmaDK regains its authorisation

The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.

Danish Medicines Agency

3-3-2017

New transatlantic agreement on mutual recognition of inspections

New transatlantic agreement on mutual recognition of inspections

The EU and the USA have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.

Danish Medicines Agency

13-2-2017

New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems

New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems

The Good Clinical Practice (GCP) inspectors of the EU member states have published a new Q&A based on the pitfalls for sponsors to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials.

Danish Medicines Agency

5-9-2016

Improved access to patient data in clinical trials for monitors and GCP inspectors

Improved access to patient data in clinical trials for monitors and GCP inspectors

The Danish Medicines Agency's inspectors have direct access to health information in patient records in all clinical trials on medicinal products notified from 1 July 2016.

Danish Medicines Agency

28-5-2014

More than 10,000 websites shut down in global operation

More than 10,000 websites shut down in global operation

The recent global Operation PANGEA VII resulted in the shutdown of more than 10,000 websites. The operation focused on combating online sale of counterfeit medicines and making consumers aware that they need to take care of themselves when buying medicines online. Globally, the operation led to 237 arrests, some 540,000 parcels were inspected and over 9.4 million units containing potentially life-threatening medicines were seized – worth an estimated value of more than USD 35 million. More than 10,000 we...

Danish Medicines Agency

21-10-2018

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annuall

Under the 1992 Mammography Quality Standards Act (MQSA), #FDA oversees mammography machines and regulates training for people who provide the scans. All mammography facilities must be accredited, certified by FDA or a state certifier and inspected annually https://go.usa.gov/xPnyE  pic.twitter.com/dZzQuYXsJ9

FDA - U.S. Food and Drug Administration

22-7-2018

Once on market, #FDA monitors for safety issues by collecting adverse event reports  https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t prov

Once on market, #FDA monitors for safety issues by collecting adverse event reports https://bit.ly/2mlhQ20 , reviewing published studies, ordering postmarket studies and inspecting facilities. We want to build on limits of these tools, as they don’t provide real-time information pic.twitter.com/WJMYVcAyoQ

FDA - U.S. Food and Drug Administration