Thursday, February 16, 2017

NECC's Quality Control Officer Says Test Results Ignored

By Walter F. Roche Jr.

In a soft voice and answering dozens of questions with one word: no, the woman who headed a drug compounding company's quality control program delivered devastating testimony in the second degree murder trial of the president of that now defunct company.
Annette Robinson, who said she had no formal quality control training, told the jury hearing the case against Barry J. Cadden that she took the job in 2007 and remained there until the New England Compounding Center was shut down in the wake of the deadly fungal meningitis outbreak it caused.
Under questioning by Assistant U.S. Attorney Amanda Strachan, Robinson said, "No," when asked if NECC followed a series of Standing Operating Procedures that were supposed to govern drug compounding at the Framingham, Mass. facility.
And though SOPs were supposed to be reviewed and revised annually, Robinson said she couldn't get Cadden to work on the SOPs on sterile compounding he was assigned.
"He never did them," Robinson said.
Robinson's former boss is on trial on charges of racketeering and second degree murder. He was indicted following a two year investigation of a deadly 2012 fungal meningitis outbreak caused by steroids, methylprednisolone acetate, shipped from NECC to 22 states across the country.
Robinson said that when she pushed Cadden's codefendant, Glenn Chin for his SOP reviews his answer was brief.
"F--- the SOPs," she said Chin responded.
On everything from the use of cleaning solutions, to performing daily environmental monitoring checks in clean rooms, Robinson said standards were not followed
She said flies and hair were found in the clean rooms and recurring cracks in the clean room floor where temperatures soared to 100 degrees due to failing air conditioning.
When she told Cadden about the cracks, she said he told her it could wait.
She said the air conditioning was shut down on nights and weekends and she had to be shown how to turn on the system when clean room work was done on weekends.
Asked if the facility's prescribed temperature and humidity limits were observed, she said no.
Robinson said she was assigned to send samples from lots of NECC drugs to an independent testing laboratory. She said only two samples were sent for each lot, no matter its size.
Asked if NECC ever shipped drugs that hadn't been tested or before test results were obtained, she said yes.
And when labels of the sample and the accompanying paperwork didn't match, the sample would be relabeled, she said.
Though she was in charge of quality control, Robinson said No, when asked if she was familiar with the U.S. Pharmacopeia, the standard mandated by state and federal regulators.
She said when environmental monitoring and other tests showed the presence of mold or bacteria little or nothing was done about it.
"Mold is bad," she said when asked if those test results concerned her.
Robinson said that when the results of another air monitoring test on a hood in the clean room kept coming back at a level requiring remedial action, Cadden instructed her to simply change the allowable level by a factor of three.
Strachan also questioned Robinson about a series of laboratory finding that showed NECC products were not sterile after a 14 day incubation period or did not meet specifications.
She said Cadden in some cases would order her to tell the testing laboratory not to do any further testing.
Asked whether negative test results prompted any remedial action, such as increased cleaning, Robinson answered with a string of NOs.
Strachan led Robinson through a series of test results showing the presence of mold or bacteria starting in the first quarter of 2012 all the way through the third quarter. She said she told Cadden but nothing was done.
Mold was found in a shelf where methylprednisolone acetate was stored, Robinson said.
Strachan then showed Robinson Quality Assurance reports that NECC sent to its customers on a quarterly basis. Asked if the information showing 100 per cent compliance was correct, Robinson once again said No.

No comments:

Post a Comment