Globepharm Consulting ‚ÌGMPŠÖ˜A‹Æ–±‚Ì‚²ˆÄ“à


US$ 175 million penalty for GMP Non-Compliance@Fri. 23 Apr. 2010


Dear Colleagues:

Yet again another US$ mega-million fine for GMP compliance issues (after, Schering-Plough, Abbott, Wyeth), this time issued to Genzyme. Attached please find today's New York Times report, and also the original 483s and Warning Letter that were received by Genzyme's, Allston, Massachusetts facility. This is part of a consent decree that is being negotiated with FDA.

It is always well worth reviewing your own operations to determine whether the maxim "there by the grace of God, go we!" might apply in your situation.

If we at Globepharm can assist by providing a reality check by using an independent external set of eyes, not bound by your company's internal mantras, by performing a thorough unbiased mock-FDA inspection of your facilities and operations, please let us know.

With Best Regards,

Michael Anisfeld

Globepharm 313 Pine Street (Ste 204)

Deerfield IL 60015, USA

Ph: USA +1 847 914 0922

Fx: USA +1 847 914 0988

e-mail: consulting@globepharm.org

Attachment :Genzyme-$175 million fine
@@@@@@@@Genzyme0808-483
@@@@@@@@Genzyme0902-drg-wl
@@@@@@@@Genzyme0911-drg-483







‚¨\‚µž‚ݐæF
“ú–{‘‘㗝“X
Š”Ž®‰ïŽÐƒeƒNƒgƒ‰ƒ“
“d˜bF0551-20-5530
FAX: 0551-20-5531
e-mail: info@techtran.co.jp
‘ã•\Žæ’÷–ðŽÐ’·F–q–ì•ó—¯