This improvement notice was served as the following was found;
- No temperature monitoring in the ‘VMD medicines store’ since summer 2016
- Batch expiry dating was either incorrect or product had been manufactured following dissolution of the company holding the authorisation to manufacture (SAM 006)
- Misleading statements regarding treatment size on packaging
- Product returned from Weston Super Mare store includes medical products which are stored inappropriately
- Expired medicinal products stored insecurely in at least two containers on site
- Products manufactured prior to dissolution of authorisation holder (SAM 006) have been supplied via wholesale
Measures to be taken are;
- Introduce monitoring for current and future stock. For current stock either dispose or provide justification for why product has not been adversely impacted.
- Review records and provide evidence confirming production dates
- Either dispose of products or securely retain effected products until authorisation is in place which will permit company to rework/reprocess/relabel as appropriate.
- Either dispose of products or improve storage conditions and justify retention
- Dispose of all veterinary medicines held within these containers
- Product may be distributed via retail or disposed of
An action plan is to be provided to the VMD Enforcement Team by 14 December 2016. All actions are to be resolved by 31 January 2017.
Published 13 December 2016