In a letter to pharmacist Barry Cadden, who co-founded NECC in 1998, PSI said it was “the opinion of the auditors that your operation needs to be upgraded and enhanced to be in substantial compliance” with federal pharmacy regulations.
“The auditors observed some of the compounding activities and although the technicians appeared to be performing the operation adequately, without a written procedure to follow it is not known if the activity is repeatable and reliable; and as noted throughout the report much of the documentation for the activities that is performed is inadequate,” wrote Mick Moriva, vice president of quality operations for PSI.
The report found insufficient documentation that proper sterilization procedures had been followed.
Inspectors who looked at the company’s non-sterile compounding procedures found potential contamination problems ranging from uncovered and unlabeled containers to a large hole in a ceiling panel above a workbench. The exteriors of some equipment were visibly dirty with buildups of residue.
In April 2006, George Cayer, then-president of the state pharmacy board charged with regulating the compounding industry, sent a follow-up letter to Cadden praising the company’s progress in responding to the inspection.
“As you are aware, PSI states that NECC has made significant improvements over the past months and demonstrated the ability to be compliant with state and federal regulations. The Board commends NECC on the progress to date,” Cayer wrote.
As part of the consent agreement, the company was placed on probation for one year, but the probation was stayed as part of the agreement, and no fines or other punitive action were ordered.
But the letter from the congressional committee indicates that the company got a warning letter from the FDA in December 2006.
Among the issues cited was NECC’s manipulation of a sterile injectable product that led the FDA to be “especially concerned about potential microbial contamination.”