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01252 375362

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FDA Warning Letters

FDA Warning Letters

by Claire Dugdale | Aug 19, 2025 | Blog, MHRA

The MHRA has reviewed its current approach to contacting UK Licence Holders who may be implicated by USFDA Warning Letters

FSN for Zoll Powerheart G5 AEDs

FSN for Zoll Powerheart G5 AEDs

by Claire Dugdale | Jun 16, 2025 | Blog, MHRA

FSN (Field Safety Notice) for Zoll Powerheart G5 AEDs was issued by Zoll earlier this year for G5 AEDs that may display Error Code (EC) 501.

Recent Posts

  • Communication from the GPhC regarding Regulatory Concerns
  • Professional Indemnity Insurance
  • FDA Warning Letters

Upcoming Courses

  • RP Forum – GxP Certificates for Customers and Supplier Qualification on 9 September 2025 10:00 am
  • Introduction to Good Distribution Practice Online Training on 10 September 2025 10:00 am
  • GDP/RP Cogent Gold Standard Online Training on 16 September 2025
  • GDP Audit Online Training on 1 October 2025 10:00 am
  • Licence Holder Training on 14 October 2025 10:00 am

MHRA Alerts & Recalls

Class 4 Medicines Defect Notification: Hikma Farmacêutica, Gemcitabine 2g/52.6ml concentrate for solution for infusion, EL(25)A/43
4 September 2025
Profemur Cobalt Chrome Modular Neck Hip Replacements: Higher than anticipated risk of revision surgery, metal-wear effects and component fracture (DSI/2025/005)
4 September 2025
Field Safety Notices: 25 to 29 August 2025
3 September 2025
MHRA Safety Roundup: August 2025
28 August 2025

Get In Touch

Address:
Wellesley House
10 Eelmoor Road
Farnborough
Hampshire
GU14 7QN

Phone: 01252 375362
Email: [email protected]
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