The FDA and Fort Dodge

[ramanth]

A Letter of Warning from the FDA to Fort Dodge (http://www.fda.gov/foi/warning_letters/g4602d.htm)

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.)

[Cinder & Smoke]

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

[ramanth]

I wondered what this 'redacted' was. Guess I could of asked around... *laughs*

Thanks for the lesson Phred. :D