As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
PTI
October 18, 2022 / 12:42 PM IST
‘); $ (‘#lastUpdated_’+articleId).text(resData[stkKey][‘lastupdate’]); //if(resData[stkKey][‘percentchange’] > 0){ // $ (‘#greentxt_’+articleId).removeClass(“redtxt”).addClass(“greentxt”); // $ (‘.arw_red’).removeClass(“arw_red”).addClass(“arw_green”); //}else if(resData[stkKey][‘percentchange’] < 0){ // $ (‘#greentxt_’+articleId).removeClass(“greentxt”).addClass(“redtxt”); // $ (‘.arw_green’).removeClass(“arw_green”).addClass(“arw_red”); //} if(resData[stkKey][‘percentchange’] >= 0){ $ (‘#greentxt_’+articleId).removeClass(“redtxt”).addClass(“greentxt”); //$ (‘.arw_red’).removeClass(“arw_red”).addClass(“arw_green”); $ (‘#gainlosstxt_’+articleId).find(“.arw_red”).removeClass(“arw_red”).addClass(“arw_green”); }else if(resData[stkKey][‘percentchange’] < 0){ $ (‘#greentxt_’+articleId).removeClass(“greentxt”).addClass(“redtxt”); //$ (‘.arw_green’).removeClass(“arw_green”).addClass(“arw_red”); $ (‘#gainlosstxt_’+articleId).find(‘.arw_green’).removeClass(“arw_green”).addClass(“arw_red”); } $ (‘#volumetxt_’+articleId).show(); $ (‘#vlmtxt_’+articleId).show(); $ (‘#stkvol_’+articleId).text(resData[stkKey][‘volume’]); $ (‘#td-low_’+articleId).text(resData[stkKey][‘daylow’]); $ (‘#td-high_’+articleId).text(resData[stkKey][‘dayhigh’]); $ (‘#rightcol_’+articleId).show(); }else{ $ (‘#volumetxt_’+articleId).hide(); $ (‘#vlmtxt_’+articleId).hide(); $ (‘#stkvol_’+articleId).text(”); $ (‘#td-low_’+articleId).text(”); $ (‘#td-high_’+articleId).text(”); $ (‘#rightcol_’+articleId).hide(); } $ (‘#stk-graph_’+articleId).attr(‘src’,’//appfeeds.moneycontrol.com/jsonapi/stocks/graph&format=json&watch_app=true&range=1d&type=area&ex=’+stockType+’&sc_id=’+stockId+’&width=157&height=100&source=web’); } } } }); } $ (‘.bseliveselectbox’).click(function(){ $ (‘.bselivelist’).show(); }); function bindClicksForDropdown(articleId){ $ (‘ul#stockwidgettabs_’+articleId+’ li’).click(function(){ stkId = jQuery.trim($ (this).find(‘a’).attr(‘stkid’)); $ (‘ul#stockwidgettabs_’+articleId+’ li’).find(‘a’).removeClass(‘active’); $ (this).find(‘a’).addClass(‘active’); stockWidget(‘N’,stkId,articleId); }); $ (‘#stk-b-‘+articleId).click(function(){ stkId = jQuery.trim($ (this).attr(‘stkId’)); stockWidget(‘B’,stkId,articleId); $ (‘.bselivelist’).hide(); }); $ (‘#stk-n-‘+articleId).click(function(){ stkId = jQuery.trim($ (this).attr(‘stkId’)); stockWidget(‘N’,stkId,articleId); $ (‘.bselivelist’).hide(); }); } $ (“.bselivelist”).focusout(function(){ $ (“.bselivelist”).hide(); //hide the results }); function bindMenuClicks(articleId){ $ (‘#watchlist-‘+articleId).click(function(){ var stkId = $ (this).attr(‘stkId’); overlayPopupWatchlist(0,2,1,stkId); }); $ (‘#portfolio-‘+articleId).click(function(){ var dispId = $ (this).attr(‘dispId’); pcSavePort(0,1,dispId); }); } $ (‘.mc-modal-close’).on(‘click’,function(){ $ (‘.mc-modal-wrap’).css(‘display’,’none’); $ (‘.mc-modal’).removeClass(‘success’); $ (‘.mc-modal’).removeClass(‘error’); }); function overlayPopupWatchlist(e, t, n,stkId) { $ (‘.srch_bx’).css(‘z-index’,’999′); typparam1 = n; if(readCookie(‘nnmc’)) { var lastRsrs =new Array(); lastRsrs[e]= stkId; if(lastRsrs.length > 0) { var resStr=”; var url = ‘//www.moneycontrol.com/mccode/common/saveWatchlist.php’; $ .get( “//www.moneycontrol.com/mccode/common/rhsdata.html”, function( data ) { $ (‘#backInner1_rhsPop’).html(data); $ .ajax({url:url, type:”POST”, dataType:”json”, data:{q_f:typparam1,wSec:secglbVar,wArray:lastRsrs}, success:function(d) { if(typparam1==’1′) // rhs { var appndStr=”; var newappndStr = makeMiddleRDivNew(d); appndStr = newappndStr[0]; var titStr=”;var editw=”; var typevar=”; var pparr= new Array(‘Monitoring your investments regularly is important.’,’Add your transaction details to monitor your stock`s performance.’,’You can also track your Transaction History and Capital Gains.’); var phead =’Why add to Portfolio?’; if(secglbVar ==1) { var stkdtxt=’this stock’; var fltxt=’ it ‘; typevar =’Stock ‘; if(lastRsrs.length>1){ stkdtxt=’these stocks’; typevar =’Stocks ‘;fltxt=’ them ‘; } } //var popretStr =lvPOPRHS(phead,pparr); //$ (‘#poprhsAdd’).html(popretStr); //$ (‘.btmbgnwr’).show(); var tickTxt =’‘; if(typparam1==1) { var modalContent = ‘Watchlist has been updated successfully.’; var modalStatus = ‘success’; //if error, use ‘error’ $ (‘.mc-modal-content’).text(modalContent); $ (‘.mc-modal-wrap’).css(‘display’,’flex’); $ (‘.mc-modal’).addClass(modalStatus); //var existsFlag=$ .inArray(‘added’,newappndStr[1]); //$ (‘#toptitleTXT’).html(tickTxt+typevar+’ to your watchlist’); //if(existsFlag == -1) //{ // if(lastRsrs.length > 1) // $ (‘#toptitleTXT’).html(tickTxt+typevar+’already exist in your watchlist’); // else // $ (‘#toptitleTXT’).html(tickTxt+typevar+’already exists in your watchlist’); // //} } //$ (‘.accdiv’).html(”); //$ (‘.accdiv’).html(appndStr); } }, //complete:function(d){ // if(typparam1==1) // { // watchlist_popup(‘open’); // } //} }); }); } else { var disNam =’stock’; if($ (‘#impact_option’).html()==’STOCKS’) disNam =’stock’; if($ (‘#impact_option’).html()==’MUTUAL FUNDS’) disNam =’mutual fund’; if($ (‘#impact_option’).html()==’COMMODITIES’) disNam =’commodity’; alert(‘Please select at least one ‘+disNam); } } else { AFTERLOGINCALLBACK = ‘overlayPopup(‘+e+’, ‘+t+’, ‘+n+’)’; commonPopRHS(); /*work_div = 1; typparam = t; typparam1 = n; check_login_pop(1)*/ } } function pcSavePort(param,call_pg,dispId) { var adtxt=”; if(readCookie(‘nnmc’)){ if(call_pg == “2”) { pass_sec = 2; } else { pass_sec = 1; } var url = ‘//www.moneycontrol.com/mccode/common/saveWatchlist.php’; $ .ajax({url:url, type:”POST”, //data:{q_f:3,wSec:1,dispid:$ (‘input[name=sc_dispid_port]’).val()}, data:{q_f:3,wSec:pass_sec,dispid:dispId}, dataType:”json”, success:function(d) { //var accStr= ”; //$ .each(d.ac,function(i,v) //{ // accStr+=”+v.nm+”; //}); $ .each(d.data,function(i,v) { if(v.flg == ‘0’) { var modalContent = ‘Scheme added to your portfolio.’; var modalStatus = ‘success’; //if error, use ‘error’ $ (‘.mc-modal-content’).text(modalContent); $ (‘.mc-modal-wrap’).css(‘display’,’flex’); $ (‘.mc-modal’).addClass(modalStatus); //$ (‘#acc_sel_port’).html(accStr); //$ (‘#mcpcp_addportfolio .form_field, .form_btn’).removeClass(‘disabled’); //$ (‘#mcpcp_addportfolio .form_field input, .form_field select, .form_btn input’).attr(‘disabled’, false); // //if(call_pg == “2”) //{ // adtxt =’ Scheme added to your portfolio We recommend you add transactional details to evaluate your investment better. x‘; //} //else //{ // adtxt =’ Stock added to your portfolio We recommend you add transactional details to evaluate your investment better. x‘; //} //$ (‘#mcpcp_addprof_info’).css(‘background-color’,’#eeffc8′); //$ (‘#mcpcp_addprof_info’).html(adtxt); //$ (‘#mcpcp_addprof_info’).show(); glbbid=v.id; } }); } }); } else { AFTERLOGINCALLBACK = ‘pcSavePort(‘+param+’, ‘+call_pg+’, ‘+dispId+’)’; commonPopRHS(); /*work_div = 1; typparam = t; typparam1 = n; check_login_pop(1)*/ } } function commonPopRHS(e) { /*var t = ($ (window).height() – $ (“#” + e).height()) / 2 + $ (window).scrollTop(); var n = ($ (window).width() – $ (“#” + e).width()) / 2 + $ (window).scrollLeft(); $ (“#” + e).css({ position: “absolute”, top: t, left: n }); $ (“#lightbox_cb,#” + e).fadeIn(300); $ (“#lightbox_cb”).remove(); $ (“body”).append(”); $ (“#lightbox_cb”).css({ filter: “alpha(opacity=80)” }).fadeIn()*/ $ (“#myframe”).attr(‘src’,’https://accounts.moneycontrol.com/mclogin/?d=2′); $ (“#LoginModal”).modal(); } function overlay(n) { document.getElementById(‘back’).style.width = document.body.clientWidth + “px”; document.getElementById(‘back’).style.height = document.body.clientHeight +”px”; document.getElementById(‘back’).style.display = ‘block’; jQuery.fn.center = function () { this.css(“position”,”absolute”); var topPos = ($ (window).height() – this.height() ) / 2; this.css(“top”, -topPos).show().animate({‘top’:topPos},300); this.css(“left”, ( $ (window).width() – this.width() ) / 2); return this; } setTimeout(function(){$ (‘#backInner’+n).center()},100); } function closeoverlay(n){ document.getElementById(‘back’).style.display = ‘none’; document.getElementById(‘backInner’+n).style.display = ‘none’; } stk_str=”; stk.forEach(function (stkData,index){ if(index==0){ stk_str+=stkData.stockId.trim(); }else{ stk_str+=’,’+stkData.stockId.trim(); } }); $ .get(‘//www.moneycontrol.com/techmvc/mc_apis/stock_details/?sc_id=’+stk_str, function(data) { stk.forEach(function (stkData,index){ $ (‘#stock-name-‘+stkData.stockId.trim()+’-‘+article_id).text(data[stkData.stockId.trim()][‘nse’][‘shortname’]); }); }); function redirectToTradeOpenDematAccountOnline(){ if (stock_isinid && stock_tradeType) { window.open(`https://www.moneycontrol.com/open-demat-account-online?classic=true&script_id=$ {stock_isinid}&ex=$ {stock_tradeType}&site=web&asset_class=stock&utm_source=moneycontrol&utm_medium=articlepage&utm_campaign=tradenow&utm_content=webbutton`, ‘_blank’); } }
Alembic Pharmaceuticals Ltd on Tuesday said the US health regulator has issued a Form 483 with four procedural observations after inspection of its oncology injectable formulation facility at Panelav in Gujarat.
As per the US Food and Drug Administration (USFDA), Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The USFDA had conducted an inspection at the facility located at Panelav from October 4, 2022, to October 14, 2022, Alembic Pharmaceuticals said in a regulatory filing.
“The USFDA issued a Form 483 with 4 procedural observations. None of the observations is related to data integrity, and management believes that they are addressable,” it added.
The company further said it is preparing the response to the observations, which will be submitted to the USFDA within the stipulated period.
