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The FDA and Fort Dodge
A Letter of Warning from the FDA to Fort Dodge
Nice to see some things are being done. :)
(For those that are new to the site, Fort Dodge are the makers of ProHeart 6 Heartworm Preventative injection. It's my opinion that ProHeart6 nearly killed Kia.)
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Go Get 'em, FDA!! ;)
When you read the Warning Letter Kimmy *linked* to;
you'll probably notice the notation >>>
[ redacted ]
in MANY :mad: Places throughout the letter...
That term [ redacted ] is legal-speak for
"edited out", or "removed" or "deleated" ~
to mark places where a word or wordS were "removed" from
the original text in order to guard Trade Secrets" or
"Confidential Commercial Information".
From an FDA web site:
"Ordinarily, the following information is considered trade secret
or confidential commercial information exempt from public disclosure:
. . 1.Information about device functions, mechanics, engineering,
. . . and schematic drawings not in the proposed labeling
. . 2.Proprietary physical characteristics and performance parameters
. . . not in the proposed labeling
. . 3.Device good manufacturing practice (GMP) information
. . . (if different from what is standard in the industry).
. . 4.Manufacturing quality control information.
. . 5.Non-clinical raw data.
. . 6.Clinical raw data.
. . 7.Supplier names, customer lists, production costs, inventory,
. . . failure rates of devices, device production quality control (QC)."
Although this FDA Letter makes no mention of the
Safety Issues with the Fort Dodge "ProHeart 6" heartworm injection -
this Warning IS a form of progress -
the FDA IS *watching* Fort Dodge! ;)
/s/ Phred
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I wondered what this 'redacted' was. Guess I could of asked around... *laughs*
Thanks for the lesson Phred. :D