Ameridose

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Ameridose, LLC. is a Medical Manufacturer, based in Westborough, Massachusetts. The company was founded, along with its sister company New England Compounding Center, by brothers-in-law Greg Conigliaro and Barry Cadden. [1] The owners of Ameridose are Carla R. Conigliaro, Barry J. Cadden, Lisa M. Conigliaro and Gregory A. Conigliaro. [2]

Westborough, Massachusetts Town in Massachusetts, United States

Westborough is a town in Worcester County, Massachusetts, United States. The population was 18,272 at the 2010 Census, in nearly 6,900 households. Incorporated in 1717, the town is governed under the New England open town meeting system, headed by a five-member elected Board of Selectmen whose duties include licensing, appointing various administrative positions, and calling a town meeting of citizens annually or whenever the need arises.

New England Compounding Center (NECC) was a compounding pharmacy founded in 1998. Based in Framingham, Massachusetts, NECC was a family-run business owned by Barry J. Cadden, his wife, Lisa Cadden who was also a pharmacist, and her brother Gregory Conigliaro.

Contents

History

Brothers-in-law Greg Conigliaro and Barry Cadden established Ameridose to be a large manufacturer of prescription medications for use in hospitals. The original location of the company's plant was in Framingham, Massachusetts next to its sister-companies New England Compounding Center and Medical Sales Management. In 2009, they started operations at a new location, 205 Flanders Road in nearby Westborough, [3] to accommodate the steady growth of the company.

Framingham, Massachusetts City in Massachusetts, United States

Framingham is a city in the Commonwealth of Massachusetts in the United States. Incorporated in 1700, it is within Middlesex County and the MetroWest subregion of the Greater Boston metropolitan area. The city proper covers 25 square miles (65 km2) with a population of 68,318 in 2010, making it the 14th most populous municipality in Massachusetts. As of 2017 the estimated population was 72,032. Residents voted in favor of adopting a charter to transition from a representative town meeting system to a mayor–council government in April 2017, and the municipality transitioned to city status on January 1, 2018.

Controversy

Ameridose's sister-company, New England Compounding Center (NECC), was implicated as the source of a nationwide fungal meningitis outbreak of 2012. [4] It was found that tainted batches of the steroid methylprednisolone acetate caused hundreds of cases of fungal meningitis. [5] Sixty-four deaths have been attributed to the tainted steroids.

Steroid any organic compound having sterane as a core structure

A steroid is a biologically active organic compound with four rings arranged in a specific molecular configuration. Steroids have two principal biological functions: as important components of cell membranes which alter membrane fluidity; and as signaling molecules. Hundreds of steroids are found in plants, animals and fungi. All steroids are manufactured in cells from the sterols lanosterol (opisthokonts) or cycloartenol (plants). Lanosterol and cycloartenol are derived from the cyclization of the triterpene squalene.

Although Ameridose was not the source of the outbreak, the company was largely impacted by its affiliation with NECC. Due to pressure from the state and the U.S. Food and Drug Administration (FDA) because of growing concern of their association with NECC, the company recalled all of its products and shut down operations in October 2012. In early November that year, Ameridose laid off 650 employees working in its Westborough facilities. [6]

Food and Drug Administration agency of the United States Department of Health and Human Services

The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of the FDA budget is paid by people who consume pharmaceutical products, due to the Prescription Drug User Fee Act.

The FDA began investigating Ameridose's facilities in October 2012. There were fifteen concerning observations that they made during the investigations. [7] These include the following:

On October 12, 2012, The New York Times published an article in which they interviewed employees from both NECC and Ameridose. [8] Some stated that the company was run well and seemed safe. Several others voiced their concerns with the companies. Many employees interviewed believed that Ameridose emphasized quantity and speed instead of quality and safety. The article also stated that in 2008 an inspector from the FDA found that the firm did not use adequate potency testing on their products.

<i>The New York Times</i> Daily broadsheet newspaper based in New York City

The New York Times is an American newspaper based in New York City with worldwide influence and readership. Founded in 1851, the paper has won 125 Pulitzer Prizes, more than any other newspaper. The Times is ranked 17th in the world by circulation and 2nd in the U.S.

In December 2012, FOX25 reporter Mike Beaudet interviewed a former Ameridose employee. She said employees would often see bugs and birds inside the company's buildings. [9] She also claimed that she witnessed company supervisors attempting to cover up their tracks for taking shortcuts when they learned that the FDA was going to inspect their facilities.

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References

  1. Weise, Elizabeth. "FDA Finds Contamination Issues at Ameridose." USA Today. Gannett, 13 Nov. 2012. Web. 04 Jan. 2013.
  2. Establishment Inspection Report, Food and Drug Administration
  3. March, Lauren. "Ameridose Moving to Westborough." National Commercial Real Estate News. CoStar Group, 14 Oct. 2008. Web. 04 Jan. 2013.
  4. Sampson, Zachary T. "New England Compounding Center, Blamed for Meningitis Outbreak, Files for Bankruptcy." Boston.com. The New York Times, 21 Dec. 2012. Web. 04 Jan. 2013.
  5. LeBlanc, Steve. "Governor Proposes New Compounding Pharmacy Rules." USA Today. Gannett, 04 Jan. 2013. Web. 04 Jan. 2013.
  6. Lazar, Kay, and Todd Wallack. "Ameridose, Sister Company to Pharmacy Linked to Fungal Meningitis Outbreak, Laying off Hundreds." Boston.com. The New York Times, 08 Nov. 2012. Web. 04 Jan. 2013.
  7. Fda.gov. Food and Drug Administration, n.d. Web. 04 Jan. 2013.
  8. Tavernise, Sabrina, and Andrew Pollack. "Ex-Workers Cite Safety Concerns At a Drug Firm." The New York Times. The New York Times, 13 Oct. 2012. Web. 04 Jan. 2013.
  9. Beaudet, Mike. "Former Ameridose Worker Discusses What She Calls Potentially Deadly Safety Hazards." Former Ameridose Worker Discusses What She Calls Potentially - Boston News, Weather, Sports | FOX 25 | MyFoxBoston. FOX25 Boston, 14 Dec. 2012. Web. 04 Jan. 2013.