drgunasakaran1
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2014-11-03 18:18
(3432 d 15:52 ago)

Posting: # 13827
Views: 2,659
 

 FDA released guidance on Circumstances that Constitute Delay [Regulatives / Guidelines]

Dear all,

FDA released Guidance for Industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
Helmut
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Vienna, Austria,
2014-11-09 13:37
(3426 d 20:33 ago)

@ drgunasakaran1
Posting: # 13846
Views: 1,934
 

 Refusing an inspection…

Dear Dr. Gunasakaran,

thanks for posting. Seems to be necessary: Beijing Shunxin Meihua Bio-technical Co., Ltd. 9/29/14

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