Freedom of Information request on the recent inspection of the results for Advent Bioservices completed inspection (FOI 21/1233)
Published 26 May 2022
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FOI 21/1233
1st December 2021
Dear,
Thank you for your communication to the MHRA in relation to a Freedom of Information request for:
- Information on the recent inspection of the results for Advent Bioservices completed inspection.
- Could you please point me towards where I may find this information? Where may I find the authorization number, or what the site name is listed under?
1.We would like to inform you that the inspection findings are currently subject to an on-going regulatory procedure, in that the inspection has not been closed out, therefore the information that you have requested currently cannot be disclosed.
Under the Freedom of Information Act (FOIA) certain exemptions apply to the information we can make available and this report request is subject to exemptions contained in the FOIA, namely section 30:
“Investigations and Proceedings Conducted by Public Authorities”
The report will be available when this procedure has reached its conclusion.
2.The information is exempt under Section 21 of the Freedom of Information Act (FOIA), because the information is accessible to you, as it is already in the public domain.
https://www.gov.uk/government/collections/licences-to-manufacture-or-wholesale-in-medicines
We have considered the balance of the public interest when applying this exemption. The exemption is to ensure that the regulatory authority is able to carry out it’s statutory functions efficiently, fairly, unimpeded and confidentially. Releasing confidential details into the public domain would have the effect of alerting the subject to aspects of an ongoing investigation about them and giving them forewarning to take evasive action. It would also be unfair in cases where the subject of the investigation was either found not to be in breach of legislation or was able to bring themselves into compliance without the need for any legal sanctions to be applied, thus potentially damaging their reputation. 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 us at IE&SFOI@mhra.gov.uk
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 email: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices.
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
Yours sincerely
IE&S FOI Team