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M.Vasu ★ India, 2011-11-11 14:58 (5344 d 03:52 ago) Posting: # 7658 Views: 5,327 |
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Hi Team, Can any one explain the difference between Establishment Inspection Report and 483 with proper reference. Thanks in Advance!!!!!! VM |
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Ohlbe ★★★ France, 2011-11-11 19:53 (5343 d 22:56 ago) @ M.Vasu Posting: # 7660 Views: 4,688 |
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Dear VM, A '483 is a form issued by USFDA inspectors/investigators at the end of their inspection. It is discussed during the closing meeting of the inspection. It lists what they consider to be "objectionable conditions". You have the possibility to (and should !) respond to the '483 in writing after the inspection, to explain whatever corrective and preventative action you plan to take. See here for more details. The EIR is written by the FDA inspectors/investigators after the inspection, to describe in detail what they did and saw during the inspection. As far as I know it is not sent to the site for a response, contrary to what happens with EU inspections; it is only sent once the inspection is "closed" (process described here). See here for more details on EIR. Note that '483 and EIR only refer to FDA inspections. Regards Ohlbe — Regards Ohlbe |
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M.Vasu ★ India, 2011-11-14 15:26 (5341 d 03:24 ago) @ Ohlbe Posting: # 7670 Views: 4,554 |
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Hi Ohlebe, Tnx 4 the reply.... May i know the difference between the 483, untitled letters, turbo EIR and warning letters.... Thanks, Vasu |
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Ohlbe ★★★ France, 2011-11-16 01:25 (5339 d 17:25 ago) @ M.Vasu Posting: # 7674 Views: 4,816 |
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Dear Vasu, ❝ Tnx 4 the reply.... No SMS language on the forum please. ❝ May i know the difference between the 483, untitled letters, turbo EIR and warning letters....   Turbo EIR is the computer system used by the FDA to write the 483 and EIR. For a definition of warning letters and untitled letters, see for instance on page 4 of this document. Note that the FDA will send an untitled letter rather than a warning letter when they refer to an activity not directly regulated by the FDA. However the effects of an untitled letter can be just as devastating to your business as a warning letter (just ask MDS Pharma Services or Cetero). Regards Ohlbe — Regards Ohlbe |
Ing. Helmut Schütz