Genzyme Warning Letter Update

I requested the Establishment Inspection Report (EIR) from the FDA, but I only received the Form FDA 483 with a letter that states,

“In order to help reduce processing time and costs, certain material has been deleted from the records furnished to you because preliminary review of the records indicated that the deleted information is not required to be publicly disclosed.”

FDA’s Field Management Directive 145 indicates EIRs are routinely released after an inspection is considered closed. Giving their response to my FOI request, I have to assume they don’t consider this inspection closed. This is further support by Genzyme’s 5/21/09 news release that states, “The FDA has begun the inspection process at the plant to determine if the deficiencies cited in its warning letter have been satisfactorily addressed. When the FDA issues its formal findings, Genzyme will provide an update.” (http://www.genzyme.com/corp/investors/GENZ%20PR-052109.asp)

The FDA 483 indicates that the inspection was lead by ORA and included CDER product specialist, which may account for the coordinated response (CR and Warning Letters delivered together).

My initial reaction to this coordinated response was surprise. I do not frequently see Warning Letters being issued as part of a Pre-Approval Inspection (PAI). In addition, the follow-up inspection to verify corrective actions prior to approval seems atypical.

It appears the FDA is stepping up their enforcement policies, which isn’t necessarily a bad thing. However, I am not sure about the severity of the action in this case, given there was no indication that adulterated product was found. It seems to me that the FDA should have completed an appropriate risk analysis before taking this position (see my blog posting, 5/20/09).

I still need to read the EIR before I can make any solid conclusions, but it looks like I will have to wait until the inspection is considered closed before I can get my hands on it.

In my previous GMP Notes, I neglected to include the link to Genzyme’s Feb 09 warning letter.

http://www.fda.gov/foi/warning_letters/s7123c.htm