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 observation, the facility was asked to send a written response within 30 days after the inspection.

The following changes became effective October 1, 2003:

• For a Level 1, repeat Level 1, or repeat Level 2 observation, the facility must correct the problem(s) as soon as possible. Instead of waiting to receive a Warning Letter, the facility should send a written response to FDA within 15 days after the inspection.
• For a Level 2 observation, the facility must correct the problem(s) as soon as possible. The facility should respond to FDA within 30 days after the inspection.
  [this represents no change from previous policies]

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 $1144. 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.