FDA
Home Page | CDRH Home Page | Search
| CDRH
A-Z Index | Contact CDRH
|
Information
for mammography facility personnel, inspectors, and consumers about the implementation of the Mammography Quality Standards Act of 1992 (MQSA) |
FDA’s Division of Mammography Quality and Radiation Programs has a new policy for how facilities should respond to serious inspection observations, and what follow-up actions FDA may take if facilities don’t correct their problems.
In the past, FDA usually sent facilities a Warning Letter for a Level 1, repeat Level 1, or repeat Level 2 observation. This letter asked for a written response within 15 days explaining how the facility had corrected or would correct its problems. For a Level 2 or repeat Level 3 observation, the facility was asked to send a written response within 30 days after the inspection. For a Level 3 observation, no response was requested and FDA checked on corrections during the next annual inspection.
The following changes became effective October 1, 2003:
If, after receiving a Level 2 or more severe observation, the facility’s response to the inspection’s observations appears adequate, FDA may decide that no further action is needed and will notify the facility that the matter is closed.
If the facility’s written response to the inspection observations isn’t
sufficient or the facility fails to respond, FDA may need to re-inspect the
facility to verify that it has corrected all of the problems. The cost of this
inspection is $991. Before scheduling this re-inspection, FDA may need to contact
the facility, in case the response letter was lost in the mail or was misdirected.
FDA may also decide to send the facility a Warning Letter, based on several
factors, including the severity of the problems, whether the facility responded
or responded adequately, and past history of problems. FDA will usually re-inspect
facilities after sending Warning Letters to see if serious problems continue.
Continuing violations at mammography facilities could result in FDA taking regulatory
action, such as Directed Plans of Correction, Civil Money Penalties, Suspension
or Revocation of an MQSA certificate.
Updated October 17, 2003
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH