Pharmacy in meningitis outbreak sent customers glowing report while internal tests showed widespread contaminants

Pharmacy and laboratory safety consultants said New England Compounding’s report card, sent to the Globe from a hospital that bought from the pharmacy, directly contradicts the findings of the company’s internal testing. The hospital provided the pharmacy report card on the condition it not be identified.

Three consultants who were shown the report card by the Globe said it lacks basic scientific data — such as how many tests were conducted to detect bacterial and mold contamination — that hospitals and other health facilities should have requested from the compounder to determine whether the company’s facility and products were up to the industry standards. They described it as a promotional brochure rather than a technical report.

“Their marketing material is baloney. They are just saying what they want to say,” said Stephen Runge, president of nanoCLEAN Decontamination Services, a Quincy company that decontaminates laboratory clean rooms after impurities are detected.

A New England Compounding spokesman said the company would have no comment.

Two of the three lots of steroids that have been linked to 363 cases of meningitis and joint infections across 19 states were produced during the period covered by the company’s report card, which was sent to an unknown number of its more than 3,000 customers. Those customers include hospitals, clinics, and doctors’ offices.

The report card stated that the company’s “extensive” testing of finished products for sterility and microbial contaminants had a 100 percent success rate from January through June 2012, though the report did not include the number of tests conducted. The customer report, adorned with a picture of a lab technician covered head to e in protective clothing, stated in a cover letter that its quality systems and facilities are “in a state of control.”

“The results of our internal review . . . demonstrate that NECC meets and is in continued compliance with all applicable requirements and standards,” said the report, signed by Barry Cadden, a co-owner of the company and its former lead pharmacist. Cadden encouraged customers to keep the report on file to show the Joint Commission, a private accrediting agency, and government regulators during inspections.

Elizabeth Zhani, spokeswoman for the Joint Commission, said that the agency’s inspectors do not specifically ask hospitals for a copy of sterility reports from their outside compounding pharmacies. Instead, inspectors typically review copies of contracts a hospital signs with outside contractors, including compounding pharmacies. The commission’s regulations do not specify whether those contracts must include reports from pharmacies about sterility testing.

New England Compounding closed earlier this month and state regulators have sought permanent surrender of its pharmacy license, as well as permanent revocation of the licenses of the company’s three pharmacists, including Cadden and his wife, Lisa Conigliaro Cadden. The Food and Drug Administration, which is among several federal and state agencies investigating New England Compounding, released a report Friday depicting lax safety practices and widespread contamination inside the company’s labs between January and September.

Federal investigators found visible mold, including 83 vials from one lot of the tainted steroid used to treat back pain that contained “greenish black foreign matter.” That lot was produced in August.

The FDA report said that the company’s own environmental testing showed bacteria and mold in numerous spots in two clean rooms that were at levels above New England Compounding’s own “action limits” — the level at which remedial action should be taken to remove contaminants. But there is no evidence that the company investigated further or took corrective measures, the report said.

And, the company did not assess whether products made in the rooms on the days samples were taken could have become contaminated.