No 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). 

The category NAI signifies no action indicated. This means that the laboratory is essentially in comphance with the GLP regulations. Ordinarily the inspected facihty receives no further correspondence from the agency concerning the inspection, and reinspection is scheduled on a routine basis. 

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. 

NAI No Action Indicated (most favorable FDA postinspection classification)... 

High temp. Fiiv. liot weather Over-pressure HF release possible injuries/fatalities Local temperature indication on water heating loop 7 No action Unlike. ... 

ISO 10012 requires that the integrity of measuring equipment be confirmed at appropriate intervals established on the basis of stability, purpose, and usage. With new equipment it is customary to set the frequency at 12-month intervals unless recommended otherwise by the manufacturer. Often this frequency remains despite evidence during calibration that accuracy and precision is no longer stable. Such action indicates that the calibration staff have not been properly trained or that cost rather than quality... 

Each cell in tlie matrix (Table 18.4.2) is assigned a risk ranking as indicated by the letters. In this approach, an A level risk corresponds to a very severe consequence with a high likelihood of occurrence. Action must be taken, and it must be taken promptly. At tlie other end of the scale, a E level risk is of little or no consequence witli a low likelihood of occurrence, and no action is needed or justified. For example, a level C risk might warrant mitigation witli engineering and/or administrative controls or may represent risks tliat are acceptable with controls and procedures. 

Testing should include a dielectric strength test to confirm the oil s insulation capability and an acidity test, which indicates oil oxidation. While acid formation does not usually develop until the oil has been in service for some time when it does occur the process can be rapid. If acidity is below 0.5 mg KOH/g no action would seem necessary. Between 0.5 and 1 mg KOH/g, increased care and testing is essential. Above 1 the oil should be removed and either reconditioned or discarded. Before the unit is filled with a fresh charge of oil it should be flushed. 

A second measurement series illustrates the lasing action of the dye droplet, where consecutively loaded droplets are pumped at different average pump power. The measured spectra shown in Fig. 17.7 show the dye droplet output power vs. pump power. In the measurement sequence, the pump power was first increased from 150 to 900 mW and subsequently decreased again. The reproducibility of the obtained spectra and the lasing threshold are seen from Fig. 17.7, respectively. The experiments reveal no significant indication of neither bleaching nor evaporation. 

Whereas benzodiazepines possessing agonist activity indirectly augment chloride permeability, inverse agonists exert an opposite action. These substances give rise to pronounced restlessness, excitement, anxiety, and convulsive seizures. There is, as yet, no therapeutic indication for their use. 

In all experiments the aqueous phases on both sides of the black lipid film were identical. Therefore, no membrane potential can be expected. The protein-covered membrane showed no membrane potential, which indicates that once the protein has penetrated through the film, the surface of the black lipid film is covered identically on both sides. Therefore, no action potential phenomena as demonstrated in other membranes by Mueller and Rudin (10) are to be expected in this kind of film. 

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