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RegisterEIR & 483 [Regulatives / Guidelines]
Dear Vasu,
No SMS language on the forum please.
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
❝ 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
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Regards
Ohlbe
Regards
Ohlbe
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