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Apr 23 2013

FDA Finds Fault With 28 Compounding Pharmacies In 26 States

Posted in Community Service, Nursing Home, Product Liability

We all recall the meningitis outbreak last fall that resulted in 722 cases of disease and 50 deaths were linked to a compounding company in Massachusetts, says Alabama liability attorney Keith T. Belt

FDA inspectors found 28 compounding pharmacies, in 26 states, making sterile products to be violating federal standards. Also this week: NICUs urged to be serious about B. cereus.

Compounding Pharacies in the following states were effected:

  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • Florida
  • Georgia
  • Illinois
  • Indiana
  • Kansas
  • Massachusetts
  • Michigan
  • Mississippi
  • Missouri
  • New Jersey
  • Nevada
  • North Carolina
  • Ohio
  • Oklahoma
  • Pennsylvania
  • South Carolina
  • Tennessee
  • Texas
  • Utah
  • Virginia

FDA inspectors issued violation notices to 28 compounding pharmacies after surprise inspections — that is, nearly every pharmacy they visited that was producing supposedly sterile drugs. According to the agency, all but one resulted in “Form 483” notices listing deviations from safe drug production standards.

Among the deficiencies:

  • “Unidentified black particles floating in vials of supposedly sterile medicine”
  • Mold in clean rooms
  • Workers handling sterile products with their bare hands and wearing non-sterile lab coats

The agency also noted that four of the pharmacies were initially uncooperative forcing the inspectors to obtain court-issued warrants before they were allowed full access to the facilities. In other cases, access to records or the areas where compounding took place was refused until the pharmacies’ lawyers were consulted. Following the inspections, several of the pharmacies issued voluntary recalls and others stopped production in order to correct problems, according to FDA Commissioner Margaret Hamburg, MD.

Shortly after the FDA report came out, a compounding pharmacy not among those inspected, Green Valley Drugs of Henderson, Nev., recalled all sterile products it had distributed because of possible contamination. The list of specific products ran into the hundreds.

 

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