Voluntary action indicated

The lead investigator is responsible for the preparation of the EIR. Other members of the inspection team may be called upon to participate in its preparation, however, particularly in supplying specialized scientific or technical information. The field investigator and the supervisor at the district office will tentatively classify the completed EIR under one of the following three categories No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI). 

Prior to December 1993, the classifications VAI-1, VAI-2, and VAI-3 were used to characterize the GLP comphance of an inspected facility. The category VAI means voluntary action indicated. The numerals 1, 2, and 3 formerly indicated degrees of failure to comply with the GLP regulations VAI-1 meant that the violations were minor and may have been corrected before the inspections was concluded, and VAI-2 indicated that minor procedural deficiencies were found that did not threaten to compromise the validity of any studies done under those circumstances. Those GLP inspections that were formerly classified VAI-1 and 2 are now termed VAI. 

In addition to providing a form FDA-483, FDA investigators prepare an establishment inspection report (EIR), which is sent to FDA headquarters, which then evaluates the report and determines the corrective action, if any. The FDA then classifies the inspection as no action indicated, voluntary action indicated, or official action indicated. The EIR contains much greater detail than contained in the 483 and is not provided to the manufacturer until after the inspection is deemed closed. 

The FDA Web site contains a list of the testing facilities that have been inspected since October 1,1989 [39], The list provides the current name and former (if known) names of the testing facility, the dates the facility has been inspected, and the classification of the inspection results. Active toxicology laboratories, university laboratories, foreign laboratories, and inactive laboratories are listed. The list is updated quarterly. The most common outcome of inspections include NAI (no action indicated), VAI (voluntary action indicated), and OAI (official action indicated). For inspections with an OAI classification, regulatory and administrative actions will be recommended. Warning letters may or may not be issued with an OAI classification. 

VAI (Voluntary Action Indicated) An informational letter that identifies deviations from regulations and good investigational practice. This letter may or may not require a response from the clinical investigator. If a response is requested, the letter will describe what is necessary and provide the name of a contact person. 

Voluntary Action Indicated (FDA postaudit inspection classification)... 

As figure 3-H indicates, in addition to the CNS (brain and spinal cord) the nervous system contains a further division, the peripheral nervous system (PNS). Within the PNS is the somatic division, which controls voluntary action of the skeletal muscles and carries information from sensory organs to the CNS. 

Section 8(e), which requires industry to notify the EPA Administrator if it obtains information indicating that a substance presents a substantial risk, has been a fertile source of information about chemical hazards. More than 400 substantial risk notices have been filed. However, the connection between information and action is unclear with respect to the notices. I do not know of any action, either regulatory or voluntary, by either industry or EPA, that has been taken as a result of an 8(e) notice. Undoubtedly, there have been some industry actions. The apparent lack of attention by the government is more troublesome, and the recent "100-day report" by OTS identifies the need to make response to 8(e) notices a matter of higher priority. 

Preventative measures may be taken in order to avoid or mitigate possible harm from uncertain risks and this will depend on the degree of importance and indeed harm of such risks. The prudent avoidance concept is defined as the full set of voluntary measures that can be taken by private individuals to minimize any unnecessary and/or easily avoidable exposure. The precautionary approach is, on the other hand, a risk management tool allowing decision makers to take action when scientific indications of possible serious and irreversible health hazards are judged to be sufficient to establish reasonable doubt . Preventative measures, however, cannot be based on a hypothetical risk. 

Grand Jury Proceedings. When the information obtainable from public sources and through voluntary industrial channels is sufficient to indicate that criminal action is warranted, a grand jury proceeding may be instituted in order to investigate conditions more thoroughly. 

The drug is observed to minimise voluntary muscle spasm by a central effect. However, the indications for the citrate are considered usually as an adjunct for the relief of discomfort amalgamated with severe painful musculoskeletal conditions, which is not yet vividly understood, but that may be associated with the analgesic characteristics of the drug substance. It has been duly observed that it does not exert its action by relaxing directly the tense skeletal muscles in man. However, the observed peripheral atropine-like actions are relatively mild in nature. Importantly, it helps to minimise voluntary muscle spasm by virtue of its central inhibitory activity specifically on the cerebral motor areas of eourse, an apparent central effect very much identical to that of atropine. 

The treaty requires that chemical attacks should be investigated, and that the victims of such attacks should be assisted (including states parties that feel threatened by activities prohibited under the treaty). It obligates all states parties to proffer assistance, establishes a voluntary fund for this purpose, and indicates procedures for the rapid provision of detection systems, protective equipment, medical antidotes, advice and other assistance. Should the Technical Secretariat uncover evidence of non-compliance, the Executive Council must first consult with the states concerned, and, if necessary, set deadlines for corrective action to be taken. Should these measures prove insufficient, the Executive Council may refer the matter to the Conference of the States Parties, which may decide to recommend a collective response. In cases of particular gravity , the Conference is required to bring the issue before the UN General Assembly and the UN Security Council. 

It is possible to derive direct and objective definitions of the other success indices in Figure 7.3 and to use these to estimate overall achievement. Involvement, for example, can be defined by recording participation in voluntary programs, and incidents of corrective action can be counted in a number of situations. You can chart the number of safety work orders turned in and completed, the number of safety audits conducted and safety suggestions given, and the number of safety improvements occurring as a result of near-hit reports. 

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