Stock from either facility (USA or Costa Rica) may ship internationally; SBCs should consider if registration of both facilities is required. The date of implementation is the 8 August 17. However do give me some time as we wait for the MBC to clarify.
The following will change:
Manufacturer Address,
Country of Manufacture,
ISO certificate change including
ISO 13485, ISO 11135, ISO 11137, etc.. Sterigenics,
Costa Rica will be the new sterilizer.
New labels will be released for this site.
Production equipment will copied from the Marlboro site.
New production facility will be validated.
A new KCE form showing manufacturing flow for Costa Rice will be released.
Do let me know if you are affected by 29 December 16. Please refer to the excel sheet for more detail.