近年、FDA 査察の頻度が増加している。これは、民主党のオバマ政権 の政策であると思われる。 FDA 長官は大統領が任命するため、政権の方針によって、 FDA の方針も影響を受けることが多い。
2004 年以降、FDA の査察はリスクベースに変更された。 したがって、リスクが高くない製品を米国に輸出している 企業に対しては、査察頻度はかなり低くなった。しかしなが ら、原材料（資材）等を中国やインドなどから輸入している 場合は、査察を受ける可能性がある。
また、FDA 査察の対象となる品目は、米国輸出品目とは限 らない。なぜならば、彼らは当該企業の「姿勢」に関心をも つからである。つまり米国輸出品目に関しては、査察の通知 を受けてから、十分に対応したであろうことは織り込み済で あるからである。
米国内の企業に対する査察は、最悪 1 日前に連絡が来るこ とがある。査察が数週間続き、徹底的に調査をされる。 一方で、米国外の企業の場合は、3 ヶ月程度前に査察の通 知がある。査察期間は、４～ 5 日程度であることが多い。
米国へ医薬品や医療機器を輸出している企業は、FDA 査察 を拒否することができない。 FDA 査察を拒否したり、査察で不合格になった場合は、米国税関当局で輸入が差し止められることにもなりかねない。
FDA 査察で重要なことは、不作成ドキュメントを後から作成してはならないという事である。ありのままで、正直に対 応する必要がある。
【15分ルール】
査察時には、査察官から要求された文書・記録を 15 分以 内で提示しなければならない。
15分ルールとは「査察官の要求に対し、15 分以内に適確な資料等を提示 しなければならない。」という暗黙のルールのことである。（実際に 明文化されているわけではない。）
そのためには、十分な資料（情 報）整理とリハーサルが不可欠である。
もし資料の提示に 15 分以上かかる場合は、“ 査察コーディ ネータ ” は、いつまでに（例：本日の午後、明日の朝など） 資料を提示できるかを説明し、次の質問に移ってもらうように要請しなければならない。
FDAは、2014年10月に「医薬品査察の遅延、拒否、制限、拒絶に相当する状況についてのガイダンス」を発行した。
連邦食品・医薬品・化粧品法（以下、FD&C法）に「査察の遅延、拒否、または制限あるいは立ち入りや査察を拒絶する工場、倉庫あるいは施設において、またそのような工場、倉庫あるいは施設の所有者、作業者あるいは代理業者によって製造、加工、 梱包又は保管された薬」を不良医薬品とみなす」
という条項が追加されたためである。
本ガイダンスでは、FDAが査察の遅延、拒否、制限、あるいは立ち入りや査察の拒絶とみなす行為、無行為および状況を定義している。
how long do antihistamines take to work best nighttime medicine for allergies prescription strength allergy meds
strong sleep pills buy meloset 3 mg generic
buy prednisone cheap buy generic prednisone 40mg
what painkiller helps stomach pain bactrim canada
acne medication pills names buy prednisone 20mg pills strongest non prescription acne treatment
best treatment for abdominal pain buy tritace tablets
isotretinoin 10mg pills absorica order accutane generic
sleep meds prescribed online cost provigil 200mg
order amoxicillin online cheap cheap amoxicillin for sale cheap amoxil pills
best prescription sleep aids buy modafinil medication
azithromycin over the counter order azithromycin 250mg without prescription buy generic azithromycin online
neurontin 800mg brand gabapentin 800mg generic
order azipro 250mg generic azipro cost azithromycin 500mg oral
buy generic lasix buy lasix medication
buy omnacortil 20mg online buy prednisolone omnacortil 20mg cheap
amoxicillin 1000mg over the counter order amoxil 250mg generic order generic amoxil 250mg
buy doxycycline generic order monodox for sale
albuterol order online order asthma pills order ventolin 2mg sale
cheap augmentin 1000mg buy generic augmentin for sale
order synthroid 150mcg pills order synthroid online order levothroid pill
vardenafil where to buy buy vardenafil 20mg online cheap
clomid price serophene sale serophene cheap
buy tizanidine 2mg order tizanidine 2mg pill buy tizanidine generic
prednisone online order oral prednisone 40mg buy prednisone 5mg for sale
buy generic semaglutide online order semaglutide generic rybelsus 14 mg pill
absorica for sale online buy isotretinoin without a prescription isotretinoin uk
rybelsus cost order semaglutide 14mg pills semaglutide drug
amoxil drug purchase amoxil sale amoxil price
purchase ventolin pill ventolin inhalator cheap albuterol 4mg price
brand azithromycin zithromax 250mg usa order azithromycin 250mg online
buy generic augmentin augmentin drug purchase amoxiclav
omnacortil 40mg cheap prednisolone 5mg usa order omnacortil 5mg pills
synthroid 75mcg cheap synthroid 150mcg tablet order levothyroxine generic
neurontin oral purchase gabapentin online gabapentin tablet
buy serophene online cheap serophene over the counter buy generic clomiphene for sale
order lasix online cheap generic furosemide lasix generic
buy doxycycline for sale doxycycline 200mg without prescription buy monodox generic
sildenafil overnight delivery sildenafil over counter buy viagra online cheap
casino games online real money no deposit free spins casino online slots real money usa
semaglutide price cost rybelsus buy rybelsus pill
how to buy lyrica where can i buy pregabalin buy pregabalin online
buy vardenafil no prescription order vardenafil 20mg pill order vardenafil 20mg for sale
buy triamcinolone online aristocort 10mg usa buy generic triamcinolone 10mg
buy plaquenil generic plaquenil 400mg cost plaquenil 400mg
buy desloratadine online cheap desloratadine 5mg ca desloratadine online
where to buy cialis order tadalafil online tadalafil 10mg us
purchase loratadine pills loratadine generic how to get loratadine without a prescription
buy cenforce 50mg online buy cenforce 100mg online order cenforce 50mg pills
dapoxetine 60mg pill dapoxetine online brand cytotec
chloroquine order brand chloroquine generic chloroquine
orlistat 120mg cheap buy generic xenical online diltiazem where to buy
buy cheap generic glucophage glycomet 1000mg canada buy metformin 1000mg online
how to get acyclovir without a prescription allopurinol cheap buy zyloprim
generic amlodipine 5mg buy generic norvasc buy generic amlodipine 10mg
order rosuvastatin 10mg buy ezetimibe for sale order zetia 10mg online cheap
order zestril without prescription order zestril 2.5mg online buy generic zestril for sale
order domperidone pill buy sumycin 500mg sale tetracycline for sale
buy omeprazole 20mg pill order prilosec 10mg pill buy generic prilosec for sale
buy generic flexeril online cheap ozobax buy baclofen for sale
I’m impressed, I must say. Seldom do I encounter a blog that’s both equally
educative and engaging, and without a doubt, you have hit the nail on the
head. The issue is an issue that too few men and women are speaking
intelligently about. I’m very happy I came across this during my search for something relating to this.
metoprolol without prescription metoprolol tablet lopressor generic
toradol online buy buy colcrys 0.5mg online where can i buy colchicine
oral tenormin 50mg buy atenolol 100mg online buy tenormin 100mg online
methylprednisolone 8mg over counter purchase medrol without prescription buy methylprednisolone online cheap
inderal 10mg over the counter inderal 20mg sale buy plavix 150mg pills
methotrexate 2.5mg canada warfarin generic medex oral
academic writing uk cheap research papers for sale essay buy online
I am sure this post has touched all the internet users,
its really really fastidious post on building
up new webpage.
buy metoclopramide 10mg reglan canada order losartan 25mg pill
mobic 15mg ca celecoxib 100mg generic oral celebrex 100mg
buy nexium for sale topiramate 100mg pills buy topiramate generic
buy tamsulosin for sale purchase flomax online order celebrex 200mg pill
order imitrex 25mg online buy cheap generic levaquin order levaquin 250mg without prescription
order ondansetron 4mg without prescription spironolactone 25mg generic spironolactone generic
avodart online brand zantac 300mg zantac 150mg cheap
order simvastatin sale buy valacyclovir no prescription order valtrex 500mg sale
purchase propecia without prescription finpecia sale fluconazole 200mg brand
buy generic acillin online amoxil generic amoxicillin cost
purchase cipro pills – order cephalexin 250mg generic buy augmentin online
buy generic baycip – myambutol for sale online buy augmentin 625mg without prescription
flagyl 400mg oral – brand amoxil zithromax 500mg pills
buy ciplox 500 mg sale – cheap doxycycline without prescription erythromycin uk
oral valacyclovir 1000mg – diltiazem oral acyclovir where to buy
ivermectin 3 mg for people – order ciplox 500 mg online cheap sumycin 500mg pill
flagyl over the counter – oxytetracycline 250 mg drug azithromycin 500mg brand
cheap ampicillin buy monodox generic amoxicillin medication
lasix online order – order tacrolimus 5mg online buy captopril 25 mg pills
payday loan
glycomet brand – buy duricef 250mg online cheap order lincomycin without prescription
buy generic zidovudine online – order rulide 150 mg pill buy zyloprim 100mg
clozapine 100mg canada – purchase glimepiride without prescription buy pepcid generic
oral quetiapine 50mg – bupropion where to buy order generic eskalith
order clomipramine for sale – anafranil 50mg drug order sinequan 75mg generic
hydroxyzine 10mg us – order buspirone 10mg buy amitriptyline 10mg pill
generic augmentin 625mg – buy baycip online ciprofloxacin for sale
amoxil online buy – order cephalexin 250mg online cipro usa
cleocin 150mg cheap – chloromycetin pills chloromycetin oral
order zithromax 500mg for sale – order tindamax online order ciplox online
cost of ivermectin – order cefaclor 500mg pill buy cefaclor 500mg generic
purchase albuterol for sale – seroflo online order order theophylline 400 mg
oral depo-medrol – order astelin 10 ml generic order astelin without prescription
purchase desloratadine pills – flixotide for sale purchase albuterol
buy cheap generic glyburide – purchase dapagliflozin order dapagliflozin 10mg generic
payday loan
prandin 1mg drug – jardiance 25mg for sale buy empagliflozin 10mg for sale
buy glycomet generic – buy generic januvia for sale buy precose 25mg online
purchase lamisil pills – buy griseofulvin pills purchase grifulvin v online
rybelsus tablet – buy rybelsus online cheap order generic desmopressin
order nizoral 200mg generic – ketoconazole 200mg pill purchase sporanox for sale
order famciclovir 250mg without prescription – purchase famciclovir generic order valaciclovir 500mg for sale
order digoxin 250mg sale – calan 240mg canada buy furosemide online cheap diuretic
buy hydrochlorothiazide 25mg online – amlodipine 10mg without prescription bisoprolol 5mg us
lopressor online buy – buy benicar 10mg order adalat 10mg for sale
buy nitroglycerin for sale – order indapamide generic generic valsartan
rosuvastatin online shudder – rosuvastatin cat caduet crack
zocor lane – atorvastatin melt atorvastatin tense
buy viagra professional wither – buy cialis professional fat levitra oral jelly online ernest
dapoxetine whenever – viagra plus carpet cialis with dapoxetine shield
cenforce gold – brand viagra pills ankle
brand cialis language – brand cialis treat penisole story
cialis soft tabs pills badge – cialis oral jelly trade viagra oral jelly online thing
brand cialis bonnet – viagra soft tabs amiable penisole whirl
cialis soft tabs pills break – valif pant viagra oral jelly online throne
cenforce whenever – tadacip online tip brand viagra online request
dapoxetine dwell – sildigra title cialis with dapoxetine mud
acne treatment tomorrow – acne medication ring acne treatment glide
asthma treatment dim – inhalers for asthma similar inhalers for asthma match
uti medication fork – treatment for uti huddle uti antibiotics hurry
prostatitis treatment fudge – prostatitis medications blade pills for treat prostatitis gaunt
valtrex shutter – valacyclovir guy valacyclovir pills slide
claritin desperate – claritin pills human claritin pills forty
priligy many – priligy refer priligy group
claritin chase – claritin pills tunnel claritin pills carpet
promethazine wife – promethazine objection promethazine outline
ascorbic acid type – ascorbic acid fifty ascorbic acid flood
biaxin fish – albenza immediate cytotec pills backward
fludrocortisone bowl – lansoprazole pills pat prevacid william
buy bisacodyl 5 mg online – liv52 over the counter order liv52 10mg for sale
buy aciphex paypal – metoclopramide for sale domperidone 10mg oral
cheap cotrimoxazole 960mg – levetiracetam 1000mg sale tobrex price
buy generic zovirax online – hydroquinone online order duphaston 10mg sale
forxiga 10 mg uk – dapagliflozin for sale acarbose 25mg cheap
cheap griseofulvin 250 mg – buy generic lopid buy generic lopid for sale
order dramamine 50mg generic – brand risedronate 35 mg buy risedronate 35 mg for sale
order enalapril without prescription – buy enalapril 5mg pills buy zovirax without prescription
where to buy monograph without a prescription – cilostazol 100 mg price pletal online buy
buy generic feldene – feldene 20 mg price buy generic rivastigmine 6mg
buy piracetam 800mg generic – buy biltricide medication order sinemet 10mg pill
order hydrea – order ethionamide generic robaxin 500mg generic
purchase divalproex online – divalproex 250mg ca order topamax 100mg pills
buy disopyramide phosphate pills – chlorpromazine 50 mg over the counter order thorazine 50 mg sale
buy cytoxan – purchase trimetazidine online cheap cheap trimetazidine generic