FDA 483 Observations and Warning Letter Trends - FDAnews
FDA 483 Observations
and Warning Letter
Trends
Chalana Damron
Crowell & Moring
General Overview:
FDA Structure and
Enforcement
U.S. Food and Drug Administration
Broad Regulatory Authority
Jurisdiction defined by the Federal Food,
Drug, and Cosmetic Act (FDCA) and the
Public Health Service Act.
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Human food, including dietary
supplements and color additives
Rx and OTC medications, and APIs
Vaccines, blood products, and
biologics
Medical devices
Radiation-emitting products
Cosmetics
Animal food, feed, and veterinary
medicines
Tobacco products
Enforcement
Form 483s
Warning Letters
Seizure
Injunction
?Notifies management
at the conclusion of
an inspection of
objectionable
conditions
?Does not constitute a
final Agency
determination
?Companies are
encouraged to
respond
?Sent by FDA to advise
of violations
?Request written
response as to steps
taken to address
violation
?Action brought
against product that is
adulterated and/or
misbranded
?Removes violating
products from
commerce
?Court-ordered
?May be sought by
FDA to require an
individual or
corporation to do or
refrain from doing a
specific act
Criminal
Prosecution &
Fines
?May recommend
prosecution for
certain violations
?Fines ranging from
$100k-500k;
imprisonment for up
to 1 year
FDA Enforcement
Trends: 483
Observations
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