Last year I did several stories on a FDA investigation into what federal inspectors determined were tainted alcohol wipes. The company at the center of this is Wisconsin based Triad Group. These wipes prompted several lawsuits from people who claimed a nasty bacteria called Bacillus cereus made them sick. A Houston family is among those suing the company; claiming these wipes led to the death of their toddler. These pads were one of the most widely used alcohol pads in the country. The company eventually shut down production after truck loads of products were seized. Now FDA officials are reporting those products have been destroyed. Below is a copy of an email I received from FDA officials regarding the status of the investigation and the company.
* Although FDA ultimately approved a “reconditioning plan” that does not mean that FDA allowed the seized articles to be put back into commerce. Reconditioning, as the term is used in FDA consent decrees, refers to bringing the articles into compliance with the law, which in many cases means destroying the seized articles.
* As the correspondence indicates, under the approved reconditioning plan all seized articles that were finished products were destroyed. Also, seized articles that were in-process (i.e, being produced) were destroyed.
* Ultimately, under the approved reconditioning plan, the only seized articles that were not destroyed were un-expired raw materials that had been received by H&P but never opened.
* Approximately 50 truck loads of finished goods, 13 truck loads of raw chemical ingredients, and 5 bulk tank trailers of in-process materials were destroyed. The articles destroyed included both articles that had been seized and other materials in H&P’s possession that had not been seized (such as recalled and returned product).
* Pursuant to the injunctive requirements of the consent decree the firm may not resume operations until FDA notifies the firm in writing that it may resume operations.
* Consistent with paragraph 17 of the consent decree, the government has informed the clerk of court that the bond can be released. The bond was canceled after the reconditioning and destruction under the approved reconditioning plan was completed under the supervision of FDA. The injunctive provisions of the Decree spell out what the firm needs to do in order to resume manufacturing drugs and medical devices.
* FDA’s correspondence to the firm outlined the deficiencies with proposed reconditioning plans, and required necessary detail.
* The firm is currently not permitted to manufacture drugs or devices.
* The firm will not be permitted to resume operations until FDA is satisfied that it can do so in full compliance with the decree and the law. If the firm is ultimately permitted to resume operations, paragraph 23 of the consent decree permits FDA to take take swift and broad action in the event violations occur.
I also recently updated a story about several lawsuits and increased scrutiny over the use of medical mesh to treat Pelvic Organ Prolapse. Here is a link to the most recent story. Now comes word that several lawmakers have filed a bill that would tighten the way the FDA “clears” medical devices for market. The FDA is facing a lot of criticism over its process process medical devices. Here is a link to story about the proposed law.
My last update is about the amount of cash seized at airports in our region. If you have ever traveled internationally then you are familiar the Customs form that asks if you are traveling with more than $10,000 in currency. If you are carrying more than $10,000 in currency you have to declare the money. If you don’t declare the cash and Customs and Border Protection Officers find the money, then it is seized and becomes property of the federal government. I am constantly coming across cases filed in federal court regarding international travelers who lie to Customs officers about the amount of money they are carrying on their trip. I just checked with Customs and Border Protection and found for fiscal year 2011 officers seized $2,134,901 in cash from travelers at airports from Corpus Christi to Dallas. Check, please!