Regulatory
Outlook
2%
28%
58%
12%
GLP IRB
S/M
CI
Figure 2. CDRH BIMO inspections in FY
2007.
district office received warning letters,
which accounted for almost 20% of
the total number issued by CDRH—
even though the Denver district receives only about 3% of the device
BIMO inspection requests annually.
Moreover, five of the 19 FDA district
offices (Cincinnati, Denver, Dallas,
New Orleans, and Seattle) accounted
for 62% of all the warning letters issued by CDRH BIMO. These data are
Number of Warning Letters
3
2
1
0
CIN
DAL
DEN
LOS
MIN
SAN
CIN
DEN
DET
LOS
S/M CI
NOL
NYK
PHI
SEA
CHI
DAL
DET
NWE
IRB
Figure 3. CDRH BIMO warning letters by FDA district and entity.
again surprising because those five
districts generally receive about 25%
of all BIMO inspection assignments in
a given fiscal year.
One explanation may be that CDRH
BIMO does a better job of focusing its
resources on high-risk device research
areas, which may account for the apparent lack of geographical warning
letter distribution. Figure 3 shows the
distribution of warning letters across
the associated FDA district
offices. The district office
names are shortened and
most are readily apparent. The exceptions may
be New England (NEW),
New Orleans (NOL), and
San Francisco (SAN).
Internally, CDRH BIMO’s Special Investigations Branch (SIB) conducted 69% of the inspections
that resulted in a warning
letter issuance (see Figure
4). SIB’s primary role is to
follow up on complaints of
NYK
