Regulatory actions against Ranbaxy Laboratories Ltd.

Kristof Wing made this Freedom of Information request to Therapeutic Goods Administration

This request has been closed to new correspondence from the public body. Contact us if you think it ought be re-opened.

The request was refused by Therapeutic Goods Administration.

Dear Therapeutic Goods Administration,

I am requesting information regarding Ranbaxy Laboratories Ltd. and its international subsidiaries, under the Freedom of Information Act.

I am requesting any of the following from between 01 January 2014 and today, 28 October 2014, regarding Ranbaxy Laboratories Ltd and its international subsidiaries:

- Any Internal Communications, including emails and letters, regarding the regulatory actions of and results of inspections undertaken by the Food and Drugs Administration or Health Canada of facilities owned and/ or managed by Ranbaxy and its subsidiaries,

- Internal Communications, including emails and letters, regarding the safety of pharmaceuticals produced by Ranbaxy and its subsidiaries which have previously received regulatory approval

I look forward to hearing from you soon either way.

Yours faithfully,

Kristof Wing

Kristof Wing left an annotation ()

So, for some background, here's an article from Pharmacy News (part of the Cirrus Media Group which publishes Australian Doctor): http://www.pharmacynews.com.au/news/late...

The TL;DR is that Ranbaxy's overseas plants (including some in Ghana and India) were falsifying the results of quality tests, and were not following Good Manufacturing Practices (GMP).
An inspection by the FDA revealed this, and importation of the raw pharmaceutical ingredients to the US was halted - there have been no statements by the TGA on the matter, as far as I can tell (there are no media releases, etc.).

A full list of Ranbaxy's products marketed in Australia, is available here: http://www.ranbaxy.com/australia/product...

Therapeutic Goods Administration

1 Attachment

Attention:  Kristof Wing

Please see attached correspondence in relation to your FOI request to the
Department of Health.

Kind regards

FOI Officer
Information Law Section| Legal Services Branch
Department of Health
Phone: (02) 6289  1718
GPO Box 9848, Canberra  ACT  2601 | MDP 350

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Dear Mr Wing

 

Please find attached correspondence relating to your Freedom of
Information request 091-1415.

 

Please do not hesitate to contact me if you have any queries.

 

Kind regards

 

Liz

 

Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792

Heather Kerr 02 6232 8163

Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

[2]cid:image003.gif@01CFA69C.488B9550

 

 

 

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"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information
and has been sent in accordance with the TGA security policy.

If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you receive
this transmission in error please notify the author Immediately and delete
all copies of this transmission."

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Timothy Fleming,

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Our reference: RQ14/02784

Agency reference: FOI 091-1415

Mr Kristof Wing

Dear Mr Wing

 

Extension of time request under s15AB

On 27 November 2014, the Therapeutic Goods Administration (TGA) requested
further time to make a decision on your FOI request of 28 October 2014.

This request was on the basis that the processing period is insufficient
to deal adequately with your request, because it is complex and/or
voluminous.

The Information Commissioner has decided to grant the TGA an extension of
time of 14 days for this request, to 11 December 2014. This decision has
been made under s15AB(2) of the Freedom of Information Act 1982 (Cth) (the
Act).

Review rights

If you are unhappy with the way we have handled this matter, you may
complain to the Commonwealth Ombudsman. This service is free, and you can
contact the office on 1300 362 072 or visit [1]www.ombudsman.gov.au.

If you would like to discuss this matter you may contact me on 02 9284
9731 or via email [2][email address].

 

Yours sincerely

 

Timothy Fleming| Investigations Officer

Office of the Australian Information Commissioner

Level 3, 175 Pitt Street, Sydney NSW 2000

GPO Box 5218 Sydney NSW 2001 |www.oaic.gov.au

Phone:  +61 2 9284 9731

Fax: +61 2 9284 9666

Email: [email address]

 

Please note: The Australian Government has introduced a Bill into
Parliament to abolish the OAIC on 31 December 2014. From 1 January 2015
privacy matters will be handled by the Australian Privacy Commissioner.
For more information about how the OAIC will handle FOI and privacy
matters until 31 December 2014  please see our [3]website.

 

Protecting information rights – advancing information policy

[4]Description: Description: Description: Description: Description:
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1 Attachment

Dear Mr Wing,

 

Please find attached correspondence relating to your Freedom of
Information request 091-1415 received 28 October 2014.

 

Kind regards

 

Emily

 

 

Freedom of Information
Liz Santolin 02 6232 8664
Karen Bedford 02 6232 8772
Emily May 02 6232 8792

Anna Theodore 02 6232 8163

Group Support Unit
Monitoring and Compliance Group
Therapeutic Goods Administration
Address: PO Box 100, Woden ACT, 2606
Email: [1][email address]

 

 

--------------------------------------------------------------------------

"Important: This transmission is intended only for the use of the
addressee and may contain confidential or legally privileged information
and has been sent in accordance with the TGA security policy.

If you are not the intended recipient, you are notified that any use or
dissemination of this communication is strictly prohibited. If you receive
this transmission in error please notify the author Immediately and delete
all copies of this transmission."

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References

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1. mailto:[email address]

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