A 483 citation is the FDA equivalent to a moving violation - too many moving violations and you run the risk of losing your driving privileges. It's not so different in the pharmaceutical world - only the fines and the consequences are far more serious.
There are those who still carelessly drive 50 m.p.h. through a school zone and believe they will not get a ticket just as there are those in the pharmaceutical industry who choose to ignore regulatory requirements in distribution and think they will not be audited.
In an article from the archives of American Pharmaceutical Review entitled Cold Chain Management - An Essential Component of the Global Pharmaceutical Supply Chain, Dr. Rafik Bishara, chair of the Pharmaceutical Cold Chain Discussion Group of the PDA takes a hard look at the increased importance of pharmaceutical cold chain management as a result of increased global regulatory oversight in the distribution channel.
Dr. Bishara has sifted through countless 483 observations by the Agency, which are a matter of public record and available through the Freedom of Information Act, and gleaned and sanitized those related to cold-chain distribution. He doesn't say what percentage they represent of all 483's given but a similar statistic from the MHRA shows that of Critical/Major Citations for Distribution Deficiencies issued in the UK in 2003-2004, nearly 25% were related to temperature control and monitoring.
You can read Dr. Bishara's article in its entirety here. I have added a Bibliography category to the column on the left to which I will soon be adding similar published articles and links. If you know of others that would be of benefit to readers of this site, please let me know, post a comment, or e-mail me directly at kevin.o'donnell@sca.com.
A note about sending solicited/unsolicited material: If you are a regular reader, you know that I do not use this venue to promote or endorse any company, including and especially my own. Nor do I criticize or judge any company, product or person. If a company, product, publication or individual is named and a link provided, it is only because it is integral to the posted article. I maintain a strict adherence to this policy as this blog is a resource meant to educate and inform those involved in pharmaceutical cold-chain and engage readers in an interesting and entertaining way.
