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Ramesh ☆ India, 2007-10-26 06:57 (6820 d 05:56 ago) Posting: # 1259 Views: 6,518 |
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Dear group members, I want some reference of the warning letters which were given for QC's not covering the subject sample concentrations. kindly do the need full. with regards, Ramesh.V — with regards, Ramesh |
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Ohlbe ★★★ France, 2007-10-31 01:36 (6815 d 10:18 ago) @ Ramesh Posting: # 1261 Views: 5,471 |
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Dear Ramesh, That's something I've seen in '483s, but I can't remember seeing it in warning letters. I had a quick look on the FDA website but I couldn't find a warning letter that includes this topic. Regards Ohlbe |
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Ramesh ☆ India, 2007-10-31 05:06 (6815 d 06:48 ago) @ Ohlbe Posting: # 1262 Views: 5,199 |
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Dear Ohlbe, Thanks for the reply. I got information regarding the QC's coverage from the workshop/conference report, AAPS journal 2007, 9(1) Article 4. It would be more helpful if i get the notice(483) issued by the FDA. with regards, Ramesh.V  — with regards, Ramesh |
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Jaime_R ★★ Barcelona, 2007-10-31 12:16 (6814 d 23:38 ago) @ Ramesh Posting: # 1263 Views: 5,712 |
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Dear Ramesh! ❝ It would be more helpful if i get the notice(483) issued by the FDA. I'm sure you don't really want to get a FORM FDA 483 (INSPECTIONAL OBSERVATIONS) issued.  Some examples of 483s can be found here. As Ohlbe already said, he couldn't find a warning letter; but if you want to give it a try yourself, here is the site to search. — Regards, Jaime |
Ing. Helmut Schütz