Food and Drug Administration investigators have found sterility problems -- including the presence of insects and a bird -- at Ameridose, a company that shares ownership with the firm tied to a deadly multistate meningitis outbreak.
Ameridose, located in Westborough, Mass., was founded in 2006 by Greg Conigliaro and Barry Cadden, who opened the New England Compounding Center (NECC) eight years earlier. In total, they own about a dozen companies.
Steroid injections for treating pain in the back and other joints made by the NECC are considered the likely source behind a 19-state fungal meningitis outbreak that has infected 428 people as of Nov. 9, killing 31. Another 10 cases of joint infections from those who got a shot in areas such as the knee, hip, shoulder and elbow have also been reported by the Centers for Disease Control and Prevention.
On Oct. 26, the FDA released a report detailing contamination, bacteria and mold growth at NECC. The agency's preliminary investigation of the Framingham, Mass. facility found that some vials of preservative-free methylprednisolone acetate tied to the outbreak contained "greenish black foreign matter" while others had "white filamentous material." That investigation also revealed the firm used non-sterile ingredients and equipment and had contamination in "clean areas."
The new FDA report on Ameridose, released Nov. 12, cites over a dozen sterility problems at the firm in addition to 33 complaints claiming ineffectiveness for products made by the company.
During the FDA's inspection of the facility, investigators observed "brownish structures" and thick residues on areas used to prepare sterile drug products. They also found "multiple insects" within 10 feet of a controlled area where sterile products are made. Investigators also observed a bird flying in the building where sterile products are packaged and stored.
Leaks were observed at the facility above "the clean room" similar to how a leaky boiler was found at the NECC.
The FDA's report also notes concerns from sterility tests at Ameridose. The report mentions microbiological contamination in one sample of sterile stock solution used to manufacture injectable drugs, but no documented evidence the firm implemented corrective actions to prevent these sterility issues from recurring.
The agency also said when the company's own sterility tests resulted in positive results, the firm considered the initial positive to be "inconclusive" or "suspect," resulting in re-testing, even though no initial laboratory cause of contamination was identified. Further, the FDA notes the company's re-testing would result in more non-sterile results.
Testing also found at least 45 samples of bacteria or mold that were isolated from critical areas such as employee's fingers or inside controlled manufacturing areas, but the FDA found no evidence of an adequate investigation by Ameridose or of permanent corrective actions implemented by the company.
The FDA also said gowns, eye-protective glasses and gloves used by personnel are not sterile.
Last Thursday, Ameridose said it would lay off nearly all its employees amid the company's prolonged closure for inspection. The company had issued a voluntary recall on Oct. 31 of all its products in circulation following an on-site investigation by the Food and Drug Administration, after which the agency told the company it wanted improvements in Ameridose's sterility testing process. Regulators had previously asked Ameridose to remain closed until Nov. 19.
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