Tuesday, June 2, 2015

Rainbow of colors in the FDA report on Massachusetts compounding pharmacy

The FDA's report on the Massachusetts compounding pharmacy at the center of the national fungal meningitis outbreak was disturbing - and colorful.

Rainbow of colors in the FDA report on Massachusetts compounding pharmacy

The FDA's report on the Massachusetts compounding pharmacy at the center of the national fungal meningitis outbreak was disturbing - and colorful.

This FDA announcement, released Friday evening, included the site inspection reports - form 483 in drug world parlance - that are supposed to show what the investigators saw when they visited the New England Compounding Center.

The first page had "greenish black foreign matter," in vials of methylprenisolone acetate.

There were "white, filamentous" material, in other vials of that medicine.

Later in the report, there were "greenish yellow" discolorations in one of the machines that is supposed to help sterilize the medicine.

Earlier reports said that NECC's parent corporation also ran a trash recycling center next store.

The investigators' report suggests the proximity of the recycling center was a problem:

"The firm is abutted to the rear and along the left parking area by a recycling facility that handles such materials as mattresses and plastics. On 10/02/12, the area was observed to include large equipment (e.g. excavators and freight trucks) producing airborne particulates (e.g. dust). Rooftop units serving the HVAC system were estimated to be located approximately 100 feet from the recycling facility.

"On 10/04/2012, we observed what appeared to be dark particulate and white, filamentous covering the louvers of an HVAC return located behind the autoclave, located in the firm's Middle Room (ISO 7). This autoclave is used for the steam sterilization of formulated bulk drug suspensions, including preservative free

formulations of methylprenisolone and triamincinolone, which are intended for injection."

A link to the 483 inspection forms is here.

 

 

About this blog
David Sell blogs about the region's pharmaceutical industry. Follow him on Facebook.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section.

Reach David at dsell@phillynews.com.

David Sell