McGuff IV vitamin C FDA warning letter

[Guest guest]

McGuff IV vitamin C FDA warning letter

McGuff Pharmaceuticals Inc. 28 Dec 2010

Unapproved New Drug and Misbranding Violations

In addition to violating CGMPs, you manufacture and market unapproved

new drugs in violation of sections 505(a) and 502(f)(1) [21 U.S.C. §§

355(a) and 352(f)(1)] of the Act. Based on the information your firm

submitted to FDA's Drug Registration and Listing System and the

information collected during the inspection of your facility, you

manufacture the following prescription drugs, including, but not limited

to:

* Ascor L 500, Ascorbic Acid Injection, USP, 500 mg/mL in 50 mL vial

(McGuff Pharmaceuticals)

* Ascorbic Acid Injection, USP, 500 mg/mL in a 50 mL vial (((6))

These products are drugs within the meaning of section 201(g) of the

Act, [21 U.S.C. § 321(g)] because they are intended for use in the

diagnosis, cure, mitigation, treatment, or prevention of diseases.

Further, they are " new drugs " within the meaning of section

201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally

recognized as safe and effective for their labeled uses. Under sections

301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)] a new

drug may not be introduced into or delivered for introduction into

interstate commerce unless an application approved by FDA under either

section 505( or (j) of the Act [21 U.S.C. § 355( or (j)] is in

effect for the drug. Based on our information, you do not have any

FDA-approved applications on file for these drug products. The marketing

of these products, or other applicable products, without an approved

application constitutes a violation of these provisions of the Act.

Additionally, because the above products are intended for conditions

that are not amenable to self-diagnosis and treatment by individuals who

are not medical practitioners, adequate directions cannot be written for

them so that a layman can use this product safely for its intended uses.

Consequently, their labeling fails to bear adequate directions for their

intended uses, causing it to be misbranded under section 502(f)(1) of

the Act [21 U.S.C. § 352(f)(1)] Because your products lack required

approved applications, they are not exempt under 21 C.F.R. § 201.115

from the requirements of section 502(f)(1) of the Act. The introduction

or delivery for introduction into interstate commerce of these products

therefore violates sections 301(a) of the Act [21 U.S.C § 331(a)].

You should discontinue manufacturing and distributing all of your

unapproved drugs at all facilities immediately. For questions about the

regulatory status of your drugs, contact Kathleen Joyce, at

301-796-3329. For assistance in communicating with the FDA concerning

the application process for your unapproved drug(s), contact FDA's

unapproved drugs coordinator, Dr. Sally Loewke, at 301-796-0710.

....

You should take prompt action to correct the violations cited in this

letter. Failure to promptly correct these violations may result in legal

action without further notice including, without limitation, seizure and

injunction. Other federal agencies may take this Warning Letter into

account when considering the award of contracts. Additionally, FDA may

withhold approval of requests for export certificates, or approval of

pending drug applications listing your facility, until the above

violations are corrected. FDA may re-inspect to verify corrective

actions have been completed.

Within fifteen working days of receipt of this letter, please notify

this office in writing of the specific steps that you have taken to

correct violations. Include an explanation of each step being taken to

prevent the recurrence of violations and copies of supporting

documentation. If you cannot complete corrective action within fifteen

working days, state the reason for the delay and the date by which you

will have completed the correction. Additionally, your response should

state if you no longer manufacture or distribute the drug products

manufactured at this facility, and provide the date(s) and reason(s) you

ceased production. For discontinued products, you must update the Drug

Listing files in accordance with 21 C.F.R. § 207.30(a)(2).

Sincerely,

Alonza E. Cruse

District Director

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm238251.htm

[Guest guest]

FDA is just as bad as the drug co. , follow the $ trail.

Someday in the near future the FDA will be shut down,

here again they do more harm then good

[Guest guest]

Rather than “shut down†the needed regulatory agency, let’s just get

rid of the money influence of the drug Company lobbyists and legislators that

enjoy the Drug Company Money. The FDA often does the right thing but too often

does the wrong thing. Can you imagine the drug companies with nobody riding

shotgun? I can’t. When we understand that Government is ‘people’ then

we come to the conclusion that it is people’s greed, not the word

‘Government’ which too many are labeling as the problem. It is corporate

greed that is the problem along with people and Legislators that feed off it.

“The Cost of Civilization, is government†and I’m sorry I don’t know who

produced that quote but it is reality because anarchy, which is the condition

without government, the free-for-all, would be horrendous. We simply must

work harder to make government work for us because no matter what country you

live in you face the same problem and sorry to say, the United States ranks

amongst the worst as regarding safeguarding We The People.

Joe C.

From: gary williams

Sent: Friday, January 07, 2011 12:12 PM

FDA is just as bad as the drug co. , follow the $ trail.

Someday in the near future the FDA will be shut down,

here again they do more harm then good

[Guest guest]

The FDA has been going after all manufacturers of IV vitamin C and of EDTA -

both quite non-toxic. Obviously these meds have greater value than we

suspected. Historical parallels tell us that the pharmaceutical industry is

developing semi-toxic high-priced versions of these that will prescriptive

control.

I remember watching a Viet Nam era documentary where General Westmoreland

was standing amidst a group of laughing, admiring wounded soldiers, when the

General spotted a soldier in the group who was wearing no bandages. The

General immediately lost his own fatuously jovial attitude and showed

immediate rage, " Why aren't you shot? " he demanded to know.

Many on this list, including myself, have gone to a clinic for a history and

physical, only to be met with confusion and disbelief when we inform them

that we are taking no prescription drugs. The feeling is that there is

something wrong with us if we are healthy. The docs will even write it up

in a negative way: " The patient denies any symptoms of. " Eventually those

who claim ownership of our health will become enraged that you have escaped

their clutches. I think it is smart to let these people give you all the

pills they want, just don't let them clog your toilet.