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Posted April 8, 2011
FDA Press Release
For Immediate Release: April 6, 2011
Media Inquiries: Shelly Burgess, 301-796-4651, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
FDA acts to prevent contamination problems with Triad antiseptic products
U.S. Marshals seize drug products manufactured and distributed by Wisconsin firms
U.S. Marshals, at the request of the U.S. Food and Drug Administration, have seized more than $6 million in products distributed by Triad Group Inc., at the company’s facility in Hartland, Wis.
Triad Group and H & P Industries are owned and managed by the same parties. A variety of drug products were seized, including povidone-iodine and benzalkonium chloride antiseptic products, cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, hemorrhoidal wipes, in-process drug products, and raw materials.
“We took this action to stop Triad from continuing to distribute products, which may pose a risk to public health,” said Dara Corrigan, FDA associate commissioner for regulatory affairs.
The action follows the continued failure of H & P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations, which are intended to assure the safety, quality, and purity of manufactured drugs. Through this seizure, FDA seeks to prevent the company from distributing product that was manufactured in violation of federally mandated manufacturing requirements.
In connection with the seizure of the medical products and related items, the First Assistant United States Attorney for the Eastern District of Wisconsin, Gregory J. Haanstad, commended officials and staff of the Food & Drug Administration and the United States Marshals Service for their highly effective, focused, and collaborative work with the Office of the United States Attorney: “The seizures at the H & P Industries facility in Hartland reflect the continuing commitment of all federal law enforcement offices to ensure the safety and the security of our populations—and to safeguard against those whose disregard of professional obligations threaten to compromise public health and well-being.”
Since December 2010, H & P Industries has initiated three voluntary product recalls due to various types of bacterial contamination found in the products.
FDA completed its most recent inspection of H&P Industries on March 28, 2011. The inspection found multiple violations of cGMP requirements, including continuing problems with the air handling system; failure to adequately investigate drug products that did not meet specifications affecting the majority of the products manufactured at the facility; and failure to take the proper measures to ensure the quality of incoming components.
Seizure of drug products is an effective remedy when there is evidence of continued poor compliance with cGMP requirements. Following a drug product seizure, companies often agree to a wide range of changes and improvements to their drug manufacturing practices at their facilities.
Due to the current unavailability of Technicare, piercers have been inquiring about what other products meet APP safety guidelines for skin preparation prior to piercing.
Betadine or other povidone iodine skin prep products can be used as described on page 29 of the APP Procedure Manual 2005 edition:
“Note: Betadine has a 3.5 minute scrub time and scrubbing must be repeated three times with separate sterile gauze pads or swabs.”
It must also be allowed to dry thoroughly before piercing takes place, and should be cleansed off of the skin before the client leaves the studio.
Research also shows a 2% Chlorhexadine Gluconate solution to be an effective skin preparation product:
Based on research studies, the CDC now strongly recommends using 2% chlorhexidine solution for skin antisepsis. Two-percent chlorhexidine solution has proven six times more effective than alcohol and povidone-iodine in cleaning the skin and in inhibiting microbial growth for days afterward. In two studies measuring persistent efficacy, chlorhexidine demonstrated significant residual antimicrobial effect over 5 days and was more effective than isopropyl alcohol, alcohol, or povidone-iodine alone.
However, although a 2% chlorhexidine-based preparation is preferred, the CDC still considers tincture of iodine or 70% alcohol as acceptable prepping alternatives.
Here is the FDA news release and below that is the CARE-TECH® Laboratories press release.
For Immediate Release: Sept. 8, 2009
Media Inquiries: Christopher Kelly, 301-796-4676, email@example.com
Consumer Inquiries: 888-INFO-FDA
Care-Tech Laboratories Agrees to Stop Making, Selling and Distributing Unapproved Antimicrobial Products
The U.S. Food and Drug Administration today announced that St. Louis-based Care-Tech Laboratories Inc. and its principal officers, John C. Brereton and Sherry L. Brereton, have signed a consent decree, agreeing to stop the illegal manufacture, marketing, and distribution of over-the-counter (OTC) antimicrobial drugs used to treat and prevent infection.
Inspectors found that Care-Tech violated numerous provisions of the FDA’s current good manufacturing practice (cGMP) regulations that direct how antimicrobial drugs are made. Additionally, the products do not conform to any applicable regulations for OTC drug products and have not undergone an FDA review, and therefore are considered unapproved drug products.
Under the terms of the consent decree, Care-Tech may not resume manufacturing and distribution of the drugs until it corrects these and other violations.
“The FDA is concerned about Care-Tech’s products because they lack FDA approval, do not conform to any applicable over-the-counter drug monograph, and are not appropriately manufactured,” said Deborah Autor, director of the FDA’s Office of Compliance, Center for Drug Evaluation and Research. “Companies have an obligation to consumers to ensure that their products are safe, effective, and high quality, and the FDA recommends that Care-Tech’s customers seek alternative products.”
Care-Tech products are sold online and through telephone orders to hospitals, nursing homes and other health care facilities. They are not sold in retail stores. The FDA is not aware of any reports of injury or illness related to the use of these products. Consumers should contact Care-Tech at 1-800-325-9681 to return products in their possession, which include:
- Caricia Care
- Clinical Care
- Formula Magic
- Loving Lather
- Loving Lather II
- Loving Lotion
- Orchid Fresh II
- Tech 2000
- Urban Skin
Health care professionals and consumers may report serious adverse events (side effects) or quality problems for these or any products to the FDA’s MedWatch Adverse Event Reporting program, online, or by regular mail, fax or phone.
- Online: http://www.fda.gov/Safety/MedWatch/default.htm
- Regular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- Fax: 800-FDA-0178
- Phone: 800-FDA-1088
For more information:
Facts About Current Good Manufacturing Practices (cGMPs) http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm169105.htm
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CARE-TECH® Laboratories, Inc.
Care-Tech® Laboratories, Inc. Suspends Manufacturing and Distribution of OTC Drug Products
ST. LOUIS, MO, September 14, 2009/ – - Care-Tech® Laboratories, Inc. announces that it has suspended manufacturing and distribution of its drug products to address concerns raised by the U.S. Food and Drug Administration (FDA). Specifically, the FDA has informed Care-Tech® that it believes the company’s over-the-counter (OTC) drug products have not been manufactured, processed, packed, and held consistent with current good manufacturing practice for drugs, which makes them presumptively adulterated under the law, even where, as here, no finished product has been found to be defective. FDA also has informed Care-Tech® that it believes these products do not conform to an OTC drug monograph, and so are considered unapproved drugs. Accordingly, Care-Tech® has agreed to suspend manufacturing and distribution of our drug products until we have fully resolved these concerns. Care-Tech® has already taken significant steps to address the issues FDA has brought to our attention, and we are working closely with agency officials to ensure any remaining issues are resolved as expeditiously as possible.
Neither FDA nor Care-Tech® is aware of any reports of injury or illness related to the use of these products, and FDA has not requested that previously distributed product be recalled. “The company is committed to ensuring that each of its products reflects the highest standards of safety and purity,” says John C. Brereton, President. “For over 100 years, patient safety has been Care-Tech® Laboratories’ first and foremost commitment. And I can assure you, it remains so today.”
The company intends to update its customers as further information becomes available.
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