This has to be the best FDA warning letter of all time:
CERTIFIED MAIL, RETURN RECEIPT REQUESTED.
November 9, 2010
Dr. Ronald A. Sherman
Co-Founder/Lab Director
Monarch Labs, LLC
17875 Sky Park Circle, Suite K,
Irvine, California 92614
Dear Dr. Sherman:
During an inspection of your firm located in Irvine, CA on June 3 through June 14, 2010, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures, markets and distributes the Medical Maggots and Maggot Confinement Dressings indicated for debriding non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers and non-healing traumatic or post surgical wounds.
Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), the Medical Maggots and Maggot Confinement Dressings are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body.
This inspection revealed that the device is adulterated within the meaning of section 501(h) of the Act (21 U.S.C. § 351(h)), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
1 comment:
What are they saying? Classic gobbledygook. I remember a section in the Washington Post years ago that used to publish such governmental statement.
BTW: I know of friends who have been treated with medical maggots. The maggots are raised in sterile conditions and have been found to help with wound healing. Maggots only consume dead, decaying flesh. So, their precision clean up work is beneficial for difficult to heal wounds. Just do some google searches. BTW: Sterile leeches are also still used.
One of the odd trivia things I learned while working at the National Cancer Institute from 1978, 1989.
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