英文字典中文字典


英文字典中文字典51ZiDian.com



中文字典辞典   英文字典 a   b   c   d   e   f   g   h   i   j   k   l   m   n   o   p   q   r   s   t   u   v   w   x   y   z       







请输入英文单字，中文词皆可：


请选择你想看的字典辞典：
单词字典翻译
483查看　483　在百度字典中的解释百度英翻中〔查看〕
483查看　483　在Google字典中的解释Google英翻中〔查看〕
483查看　483　在Yahoo字典中的解释Yahoo英翻中〔查看〕

安装中文字典英文字典查询工具!


中文字典英文字典工具:
选择颜色:
输入中英文单字

































































英文字典中文字典相关资料:


  • FDA Form 483 Frequently Asked Questions
    A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food
  • Form FDA 483 - Wikipedia
    The 483 then have a large area for recording the observations, which may be continued on several pages The observations should be ranked in order of significance If an observation made during a prior inspection has not been corrected or is a recurring observation, that may be noted on the 483 [15]
  • FDA 483 and Warning Letters: What Pharma Companies Need to Know
    FDA 483 and Warning Letters: What Pharma Companies Need to Know Compliance is the foundation of both credibility and patient safety Among the many regulatory tools the U S Food and Drug Administration (FDA) employs, the Form 483 and the subsequent Warning Letter are the most significant indicators of non-compliance within pharmaceutical manufacturing and supply operations
  • 483 vs Warning Letter: What’s The Difference?
    A 483 is issued to a company at the end of an FDA inspection, it documents any conditions that the inspector believes may violate FDA regulation Its purpose is to notify the company’s management of any conditions observed and allow them to discuss and respond Once you have received the 483 you only have 15 days to respond thoroughly
  • Demystifying FDA 483: Meaning, Significance, and Implications
    What is FDA 483? The FDA Form 483, often referred to simply as FDA 483, is a document issued by the U S Food and Drug Administration (FDA) to an inspected firm when inspectors observe any conditions or practices that may violate the Food, Drug, and Cosmetic Act Essentially, it is a list of observations made during an inspection
  • FDA Form 483 vs. FDA Warning Letters: Whats the Difference?
    An FDA Form 483 is a list of deficiencies that the FDA sends to a company post-inspection outlining what they think needs to be remediated It is strongly suggested that a company responds to these forms thoughtfully and aggressively with corrective actions The FDA wants to make sure that all pharmaceutical and biotechnology companies have
  • FDA Form 483 and Warning Letters - Pharmaguideline
    Warning Letter: After the issuance of FDA Form 483 and completion of the inspection, a regulatory agency may issue a Warning Letter to the manufacturing site When any serious issue is found regarding the quality of the product, a Warning Letter is issued by the higher officials of FDA after the review of the inspection observations It contains evidence and detailed explanations for the
  • What To Do If Youre Issued a Form FDA 483 - The FDA Group
    The FDA 483 can also be a prerequisite to an FDA Warning letter The FDA 483 that is issued to the most responsible person at the company at the conclusion of an inspection Investigators from the Food and Drug Administration's Office of Regulatory Affairs issue the form when they observe practices that can adulterate the pharmaceuticals
  • Understanding the Form FDA 483 Process and Timeline
    3 When is a Form FDA 483 issued? • A Form FDA 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed conditions that in
  • What is an FDA 483, and How Do You Respond? - Kapstone Medical
    The 483 Form must be taken seriously and addressed through appropriate corrective actions, to avoid further action being taken So, what is an FDA 483, and what are the best ways to respond? FDA 483 Explained Foreign and domestic medical device companies distributing into the US are expected to comply with FDA regulations When an FDA





中文字典-英文字典  2005-2009