Administrative Tools

Warning letters are issued when the FDA makes a conclusion

that a certain conduct violates a provision of
the Public Health Service Act or FDCA. This notifies
the facility that the FDA will take further action if the
problem is not corrected. Timelines for corrective
action are required by the FDA. The FDA ensures that
corrective action is implemented and is working.
Product recalls are used to remove a violative
product from the market and are classified according
to the nature of risk to public health. A class I recall,
for example, would be the recall of a product that presents
a risk for death or an irreversible serious health
hazard to the public.
License suspension applies to establishment or
product licenses and represents a quick process to remove
violative products from the market. It prevents
shipment or further manufacturing of all products
involved, and the FDA can proceed to revoke license
or maintain suspension until compliance issues are
resolved.
License revocation is a drastic action to prohibit
interstate commerce of products. Violations resulting
in this sanction are seen to be a health hazard to product
recipients.
The FDA gives a notice of intent to revoke license,
and the facility has 10 days to notify CBER of
the approach it will use to achieve compliance, and
30 days to submit a detailed, comprehensive action
plan, including completion dates. If the FDA perceives
a danger to public health, it may revoke the license
immediately without a Notice of Intent to
Revoke. CBER may decline to approve any license
applications or supplements until all compliance issues
are resolved. Once the license has been revoked,
the facility must apply for new licensure once violations
are corrected. The Notice of Intent to Revoke is
a public document available through FOI.

Judicial Tools
For judicial actions, all FDA enforcement litigation is
brought by the U.S. Department of Justice, on recommendation
by the agencys Chief Counsel. Actions
that may be taken include
Seizure
Injunction
Criminal prosecution
Consent Decree of Permanent Injunction
Seizure is a civil action against violative products,
not a person or company. Once products are seized,
the FDA decides if the materials will be reconditioned
or destroyed. The seizure may involve one or several
lots of product.
An injunction is a court order, requested by FDA,
used to prevent the continuance of violative behavior.
This action can be brought against both corporations

and individuals. It can shut down a specific area of

operations or the entire business, as in the case of a
repeated GMP violation history.
Criminal prosecution is generally brought against a
blood establishment and its responsible individuals in
instances where there is evidence of management disregard
for GMPs, continuing violations, serious threat to
health, or willful circumvention of the law. A Section
305 hearing provides opportunity for the facility or individuals
to present their case before initiation of criminal
proceedings. This hearing, however, is not required
if the FDA seeks an indictment from a grand jury. Penalties
include fines for misdemeanor charges and more
significant fines and imprisonment for felony charges.
The Consent Decree of Permanent Injunction is a
legal document written by or on behalf of the FDA, enforced
through a U.S. District Court, imposing specified
sanctions against the violative firm. This sanction is used
when there is an ongoing history of compliance problems
identified across various systems within a firms
operations. It usually follows an FDA-filed injunction.
Violative practices are described; corrective actions are
prescribed and agreed to with designated time frames
for completion. The district court has jurisdiction over all
provisions in the decree as they apply to the firm or its
individuals. The FDA (or designated qualified third
party) assumes direct intervention in the firms operations,
including close monitoring of all actions, adequacy
of corrective actions, and progress toward compliance.
The facility agrees to provide periodic progress reports
toFDAand to pay allFDAcosts involved in the monitoring
of the firms actions. The FDA can take immediate
enforcement actions if operations are not corrected satisfactorily
within the prescribed time frames.

Centers for Medicare and

Medicaid Services

The CMS formally known as the Health Care Finance

Administration (HCFA) is the federal agency respon-