mdi ConsultantsWarning Letter issuance – How long before the FDA issues one?
We always hear the question – “How long does the FDA take to issue a warning letter, if they are going to issue one?”
This is an interesting question because there is no official answer. It used to be that the FDA worked on a 90-day or so time frame in getting Warning Letters issued after the issuance of a 483 at the completion of the inspection of a company. Last August (2009) the new FDA Commissioner promised immediate follow up to lack of compliance to make sure that companies bring their operations into compliance. The FDA’s Regulatory Procedures Manual states the following on the time frame to issue Warning Letters as a result of the new FDA Commissioner’s statement to force industry compliance:
“Within fifteen (15) working days after completion of the inspection, or, if applicable, sample analysis, the district should submit a Warning Letter recommendation to the appropriate reviewing office for concurrence. Within fifteen (15) working days after receipt of the Warning Letter recommendation, the center should review the Warning Letter and notify the district office of its decision.”
From this RPM procedures a Warning Letter should be issued in about 30days. So, what has the FDA been doing concerning the time frame for issuing Warning Letters as a result of FDA violative inspections?
We reviewed the most recent Warning Letters (between May and June 2010) issued by the FDA to Medical Device and Pharmaceutical companies and came up with the following interesting statistics:
15 Warning letters were issued, 8 to medical device companies and 7 to pharma companies. One was issued to a foreign pharma company. These letters were issued by 10 different offices (14 by the district offices), (1 by Nashville/Cinn/Sea/Fla/NYD/LAD/CHI, 3 by NWk and 4 by SanFran) and 1 by the Center (for the foreign company). Why some districts issue more Warning Letters than others will be covered in a future FDA update.
The average time frame for the issuance of the Warning letters was 120 days. We found one issued as fast as 30 days and one issued longer than 7 months (that letter from the Center for a foreign pharma company).
Though San Fran office issued 3 warning letters at around the 120 day mark, they also had one letter issued after 6 months. NJ office had two issued in 45 days but then one was issued 6 months after the 483 was issued.
So, what does that mean to a company trying to figure out if they will be issued a Warning Letter or not as a result of their company inspection? Do not be assured that if you did not receive a Warning Letter after 90 days that you will not be issued one. A company must be very proactive in responding to the 483 and keeping the FDA informed of the corrective actions that are being taken as a result of the 483.
Right now that is the only way to prevent a warning letter from being issued. Trying to figure out what the FDA will do next is not the way to proceed. The appropriately defined corrective actions implemented in order to address full compliance are the smart way to go in preventing an FDA Warning Letter.
IIf you would like more information on how to respond to 483 observations and/or the FDA follow up to the 483, please contact mdi at [email protected]