| FDA Inspection Related
Terms - |
| ADJUDICATE
(ADJUDICATION) |
:
To make a final judgment in a lawsuit. The judgment of the
court. |
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FDA Regulatory Procedures Manual |
| ADMONITION |
A
reprimand from a judge to a person accused, on being discharged,
warning of the consequences of his conduct and should he be
guilty of same fault, he will be punished with greater severity. |
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FDA Regulatory Procedures Manual |
| AFFIDAVIT: |
A written statement made voluntarily under oath. An affidavit
may be made (a) on personal knowledge, or (b) on information
and belief. |
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FDA Regulatory Procedures Manual |
| AMERICAN
GOODS RETURNED |
Goods
produced in the United States (U.S.) which, after being exported,
are subsequently returned to the U.S. Such goods are considered
imports. |
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FDA Regulatory Procedures Manual |
| AMICUS
CURIAE |
A
friend of the court. A person who, although not a party in
a suit, is allowed to intervene to protect his interests. |
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| ANSWER |
After
filing of a Claim of Ownership in a seizure, the claimant
files an Answer in which he may deny any or all of the allegations
of the Complaint for Forfeiture. Any response to a Complaint. |
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FDA Regulatory Procedures Manual |
| APPEAL |
:
The formal review by a higher court of a lower court's disposition
of a lawsuit. |
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| AUTOMATIC
DETENTION: |
An administrative act of detaining an entry without physical
examination solely on the basis of information regarding past
violative history and/or other information which indicates
the appearance of a violation. |
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| BILL
OF PARTICULARS: |
Used in Criminal Cases only. A motion requesting the specifics
of a charge, so that defense against the charges may be properly
prepared. |
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FDA Regulatory Procedures Manual |
| CERTIORARI |
means "To be certified". A writ commanding a court to certify
records to a superior Court. When the Supreme Court grants
certiorari, that means it has agreed to hear the case. If
it denies certiorari, it will not hear the case. |
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FDA Regulatory Procedures Manual |
| CODE
OF FEDERAL REGULATIONS (CFR): |
The Code of Federal Regulations is a codification of the published
rules in the Federal Register by the Executive Departments
and Agencies of the Federal government. The CFR is divided
into 51 titles which represent broad areas subject to Federal
regulation. Each title is divided into chapters which usually
bear the name of the issuing agency. Each chapter is further
subdivided into parts covering specific regulatory areas.
FDA's regulations are in Title 21, Parts 1-1200. U.S. Customs
regulations are found under Title 19. |
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FDA Regulatory Procedures Manual |
| COMPLIANCE
ACHIEVEMENT: |
The observed repair, modification, or adjustment of a violative
condition, or the repair, modification, adjustment, relabeling,
or destruction of a violative product when either the product
or condition does not comply with the Acts enforced by the
agency. |
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FDA Regulatory Procedures Manual |
| COMPLAINT
FOR FORFEITURE: |
The document furnished to the United States Attorney for filing
with the Clerk of Court to initiate a seizure of a lot. (This
document was formerly known as a Libel of Information.) |
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FDA Regulatory Procedures Manual |
| CONSENT
DECREE OF CONDEMNATION: |
The
document entered by the court in a seizure action based on
the claimant's agreement that the article seized is in violation
as alleged in the Complaint for Forfeiture and the article
is subject to condemnation. It is also a declaration of Claimant's
intent to provide a Bond and to recondition the article under
supervision of FDA and to pay costs. |
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| CONSENT
DECREE OF INJUNCTION |
:An
injunction to which the defendant has agreed and which is
filed in court. |
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| CONTEMPT
OF COURT: |
Any act which is calculated to embarrass, hinder, or obstruct
a court in the administration of justice, or which is calculated
to lessen its authority or its dignity. |
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| CORRECTION: |
"Correction" means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring)
of a product and/or the promotional materials which cause
the product to be violative, without its physical removal
to some other location. |
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FDA Regulatory Procedures Manual |
| DEFAULT
DECREE: |
A Default Decree of Condemnation is a Court Order entered
when lots under seizure are not claimed or defended. The order
condemns the product as being in violation and provides for
destruction, donation to charity, sale, or disposal as the
Court may elect to decree. When signed by the Court, it signifies
the final adjudicatory step in a seizure action. |
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| DE
MINIMUS: |
Not
enough to be considered. |
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| DEPOSITION: |
The sworn testimony of a witness obtained outside the courtroom
before trial through examination and cross-examination by
the attorneys for the parties. |
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| DETENTION: |
Administrative act whereby FDA requires that imported articles
which appear violative under the laws FDA administers be held
intact. Detained articles may be released if brought into
compliance with or rendered not subject to the FD&C Act, or
refused entry if not brought into compliance. |
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| DISCOVERY: |
The process of obtaining information concerning the other
party's case. Methods of discovery are contained in Rule 16
of the Rules of Criminal Procedure, and Rules 26 through 37
of the Rules of Civil Procedure. |
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| ENJOIN: |
A restraint through formal Court order; to cease a practice
or to stop further violation of the Act. |
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| EXECUTION
OF DECREE: |
The carrying out of the court's order e.g., the destruction
of goods under seizure by the Marshall in response to a Default
Decree of Condemnation. |
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| FDA
ORDERED RECALL: |
"FDA
ordered recall" means a recall initiated by a firm in response
to an order for such action. Examples would be: device recalls
ordered under section 518(e), Infant Formula recalls ordered
under section 412(e)(1) of the act, and human tissue for transplantation
ordered under 21 CFR Part 1270. |
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FDA Regulatory Procedures Manual |
| FDA
REQUESTED RECALL: |
"FDA
requested recall" means a recall initiated by a firm in response
to a formal request for such action by the Associate Commissioner
for Regulatory Affairs, or the appropriate center director
when the authority has been delegated. |
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| FOR
CAUSE INSPECTION: |
An inspection that is carried out in response to specific
information that raises questions, concerns, or problems associated
with an FDA regulated firm or commodity. This information
could come to the attention of FDA from any source, and includes
but is not limited to the following: the results of a sample
analysis, observations made during prior inspection(s), recall
or market withdrawal, consumer or employee complaint, adverse
reaction report, or suspicion of fraud. |
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FDA Regulatory Procedures Manual |
| GUARANTY: |
A formal and signed agreement between buyers and sellers in
which the latter verifies the goods he sells are not in violation
of the FD&C Act when shipped. |
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FDA Regulatory Procedures Manual |
| HEALTH
FRAUD: |
The promotion, advertisement, distribution, or sale of articles,
intended for human or animal use, that are represented as
being effective to diagnose, prevent, cure, treat, or mitigate
disease (or other conditions), or to provide a beneficial
effect on health, but which have not been scientifically proven
safe and effective for such purposes. Such practices may be
intended to defraud or mislead. |
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| INJUNCTION: |
An order issued by the Court requiring a defendant to do or
refrain from doing a specified act. |
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| JUDICIAL
DISTRICT: |
Physical
parameters, set by Congress, designating the counties under
the jurisdiction of a United States District Court. |
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| MAGISTRATE:
|
A
part time or full time court official authorized to try misdemeanor
cases without a jury, and to perform certain other duties
of the court, such as issuing inspection warrants. |
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| MANDAMUS: |
A command which a superior court issues to a lower court or
a person (including a government agency), ordering it to do
its duty. |
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FDA Regulatory Procedures Manual |
| MARKET
WITHDRAWAL: |
"Market
withdrawal" means a firm's removal or correction of a distributed
product which involves a minor violation for which FDA would
not initiate legal action, or which involves no violation
(e.g., normal stock rotation practices, routine equipment
adjustments and repairs, product improvement, etc.) Replacement
of device components which fail (wear out) after a reasonable
life span will be considered a market withdrawal unless a
violation of the FD&C Act has occurred and can be supported
(e.g., failure to conduct adequate finished product testing,
or sample analysis reveals a defective product.) |
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FDA Regulatory Procedures Manual |
| MEMORANDUM
OF UNDERSTANDING (MOU) |
:
This is a formal agreement with a state or local agency. The
agreement does not involve a transfer of funds or a transfer
of personal or real property (Agreements calling for transfer
of funds, or a transfer of personal or real property are considered
Interagency Agreements, see Staff Manual Guide 2810.1). |
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FDA Regulatory Procedures Manual |
| MONITION: |
A formal order commanding something be done or not done. In
seizure actions, a monition is a warning that goods are under
the jurisdiction of a district court and nothing may be done
to them save upon a court order. |
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FDA Regulatory Procedures Manual |
| MOTION: |
An application to a court, either written or oral, for a rule
or order, such as to permit postseizure sampling. |
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| MUTUAL
RECOGNITION AGREEMENT (MRA): |
A type of memorandum of understanding that provides for the
mutual assessment of the comparability of specific FDA programs
or activities with those of a foreign regulatory authority.
An MRA is suitable as an equivalence agreement when it can
be determined that FDA's controls and the foreign regulatory
authority's controls are comparable and are designed to provide
the same level of protection. |
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FDA Regulatory Procedures Manual |
| NOLO
CONTENDERE: |
A plea in a criminal case which is essentially the same as
a guilty plea. The only difference is that a guilty plea may
be used as evidence in a subsequent civil suit against the
defendant, but a nolo plea may not be so used. A nolo plea
counts as a first offense in second offense cases. |
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FDA Regulatory Procedures Manual |
| NOTICE
OF DETENTION AND HEARING (FORM FDA-718): |
Issued
by FDA to the importer when articles offered for entry into
the U.S. appear to be in violation of the law. It affords
the importer an opportunity (10 working days) to offer testimony
indicating why the material should not be refused entry or
to discuss how the product will be brought into compliance
with the law |
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FDA Regulatory Procedures Manual |
| NOTICE
OF REFUSAL OF ADMISSION (NORA) (FORM FDA-772): |
Form issued to importer indicating that an entry of merchandise
appears violative and that it is refused admission into the
U.S. This occurs after the importer has been provided an opportunity
to present testimony concerning the violation. The shipment
must be exported or destroyed under Customs' supervision in
90 days |
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FDA Regulatory Procedures Manual |
| PERMANENT
INJUNCTION: |
A
Decree of Permanent Injunction may be entered at any time
after the complaint is filed, either following a hearing or
as a result of a negotiated settlement. Defendants in an injunction
proceeding may consent to a Decree of Permanent Injunction
just as they consent to a Consent Decree of Condemnation in
a seizure action. |
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FDA Regulatory Procedures Manual |
| PRELIMINARY
INJUNCTION: |
Whether or not a TRO has been obtained, a Motion for Preliminary
Injunction is subject to a full hearing in which (1) evidence
by affidavit, and/or (2) testimony of witnesses is presented,
depending on the practice of the court. Once the motion is
granted, or the defendants consent to the entry of a decree,
the preliminary injunction is in effect. |
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FDA Regulatory Procedures Manual |
| PRIOR
NOTICE: |
The FDA policy of notifying an individual or firm of a violation
of the Federal FD&C Act, or other acts, when voluntary correction
is an appropriate initial response to the violation. This
policy is also commonly referred to as "Prior Warning." |
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FDA Regulatory Procedures Manual |
| PROCEDURE
IN ADMIRALTY: |
Seizure
actions taken pursuant to the FD&C Act are (per Section 304(b))
to be in conformity with the procedure in admiralty, which
means the Government may initiate confiscation of articles
it deems to be contraband without having to first show proof
of the allegation or responsibility for the violation. |
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FDA Regulatory Procedures Manual |
| RECALL:
|
A
"recall" is a firm's removal or correction of a marketed product(s),
including its labeling and/or promotional materials, that
FDA considers to be in violation of the laws it administers,
and against which the agency would initiate legal action (e.g.,
seizure or the full range of administrative and civil actions
available to the agency). |
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FDA Regulatory Procedures Manual |
| REVOCATION:
|
Is
the cancellation of a license and the withdrawal of the authorization
to ship a biological product for sale, barter, or exchange
in interstate commerce either at the request of the manufacturer
or when grounds exist for the agency to initiate such an action.
|
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FDA Regulatory Procedures Manual |
| SEIZURE:
|
Attachment
of goods through Court order by a U.S. Marshal pursuant to
Section 304 of the FD&C Act. |
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FDA Regulatory Procedures Manual |
| STATUTE
OF LIMITATION: |
This is the period in which any criminal action contemplated
must be brought. In all FDC matters, the period is five (5)
years; if no prosecution is filed within that time, FDA may
not proceed. 18 U.S.C. 3282. |
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FDA Regulatory Procedures Manual |
| SUBPOENA: |
A document, issued by the Clerk of the Court which, when delivered
to the person named therein, requires him to appear in court,
or at a deposition, or before a grand jury. |
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FDA Regulatory Procedures Manual |
| SUMMARY
AND RECOMMENDATION (S& R): |
The
written justification from the District in its request for
institution of a criminal prosecution. |
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FDA Regulatory Procedures Manual |
| SUPERVISORY
CHARGES: |
The
charges for supervising the reconditioning and examination
of articles that an importer, owner, or consignee attempts
to bring into compliance after detention (See 21 CFR 1.99). |
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FDA Regulatory Procedures Manual |
| TEMPORARY
RESTRAINING ORDER: |
Temporary
restraining orders are court-enforced cease and desist orders
that are brought to control an emergency situation. A TRO
seeks immediate, temporary relief (for a period of 10 days,
which may be extended for 10 additional days) prior to the
hearing for preliminary injunction. |
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| TRIPLE
DAMAGES: |
For FDA regulated products, the amount of liquidated damages
assessed by Customs against the lot(s) not redelivered upon
Customs demand is, at this printing, triple the amount of
the lot value used by Customs to determine the rate of duty,
taxes, etc. |
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| WARNING
LETTER: |
An informal advisory to a firm communicating the agency's
position on a matter but does not commit FDA to taking enforcement
action. The agency's policy is that Warning Letters should
be issued for violations which are of regulatory significance
in that failure to adequately and promptly take corrections
may be expected to result in enforcement action should the
violation(s) continue. |
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