GxP Inspection reports for MHRA inspections of Bristol-Myers Squibb company locations

Response to this request is long overdue. By law, under all circumstances, Medicines and Healthcare Products Regulatory Agency should have responded by now (details). You can complain by requesting an internal review.

Dear Medicines and Healthcare products Regulatory Agency,

Please could you make available all MHRA Inspection reports for GxP (incorporating GMP, GDP, GCP and GVP) inspections performed by the MHRA inspection group at all global Bristol-Myers Squibb premises from Jan 2009 to Mar 2019.

Yours faithfully,
Lee

MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

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MHRA Customer Services, Medicines and Healthcare Products Regulatory Agency

Our Ref: FOI 19/164

Dear Lee,

RE: REQUEST UNDER THE FREEDOM OF INFORMATION ACT 2000

Thank you for your enquiry attached and below which we received on 3 April 2019.

I confirm that your request is now being handled under the Freedom of Information Act and you should receive a reply within 20 working days from our date of receipt.

If you need to contact us again about this request, please quote the reference number above.

Kind Regards,

Customer Services
Communications division
Medicines and Healthcare Products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone: 020 3080 6000
Email: [MHRA request email]
Stay connected: mhra.gov.uk/stayconnected

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IE&SFOI, Medicines and Healthcare Products Regulatory Agency

4 Attachments

  • Attachment

    Inspection Report Bristol Myers Squibb Pharmaceuticals Merseyside 5 7th October 2010.pdf

    4.1M Download View as HTML

  • Attachment

    Inspection Report Bristol Myers Squibb Pharmaceuticals Merseyside 23 24th May 2013.pdf

    5.8M Download View as HTML

  • Attachment

    Inspection Report Bristol Myers Squibb Pharmaceuticals Limited Uxbridge 8th 11th February 2010.pdf

    5.1M Download View as HTML

  • Attachment

    Inspection Report Bristol Myers Squibb Pharmaceuticals Merseyside 29 31 August 2017.pdf

    5.7M Download View as HTML

3^rd May 2019

 

Dear Requestor,

 

REF: FOI 19/164

 

As requested under the Freedom of Information Act, please find enclosed
all MHRA Inspection reports for GxP (incorporating GMP, GDP, GCP and GVP)
inspections performed by the MHRA inspection group at all global
Bristol-Myers Squibb premises from Jan 2009 to Mar 2019.

 

You will see that some information has been redacted. The relevant
sections of the Freedom of Information Act are marked at the side of each
redaction. These are:

 

•           Section 40 – This information contains elements of personal
data, the disclosure of which would be unfair in that it would breach the
first principle of the Data Protection Act which says that information
must be processed fairly and lawfully.

•           Section 43 – Release of all, or part of, the information
would, or would be likely to, cause harm to the third party's commercial
interests.

 

I have considered the balance of the public interest when applying this
exemption. The exemption is to safeguard the commercially sensitive
information / Trade secrets of a third party / commercial enterprise
(which can include a Government Department). This exemption is conditional
on the public interest in releasing it not outweighing the
company's/commercial enterprise's right to confidentiality and the
probable damage that the company/commercial enterprise could suffer as a
result of the information being released. In this case I have not
identified any issues which would benefit the public as a whole by being
brought to their attention (examples of issues would be a major public
health risk or a major procedural failure or irregularity) .

 

If you have a query about this letter, please do not hesitate to contact
me at [1]IE&[email address]

 

If you are unhappy with our decision, you may ask for it to be reviewed.
That review will be undertaken by a senior member of the Agency who has
not previously been involved in your request. If you wish to pursue that
option please write to the Communications Directorate, Medicines and
Healthcare products Regulatory Agency, 10 South Colonnade, Canary Wharf,
London, E14 4PU.

 

After that, if you remain dissatisfied, you may write to the Information
Commissioner at;

 

The Information Commissioner’s Office

Wycliffe House

Water Lane

Wilmslow

Cheshire

SK9 5AF

 

They will make a decision on whether or not we have interpreted the FOIA
correctly in handling your request.

 

Yours sincerely

 

IE&S FOI Team

MHRA

Inspection, Enforcement and Standards

 

cc FOI_Policy

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