The article in the Dallas Morning News was something no pharmaceutical manufacturer wants to see. The headline, “Farmers Branch pharmacies highlight lack of government oversight of custom-made drugs,” may at first appear to attack government regulations, but the article instead claimed that the managers of what is now Downing Labs refused to allow FDA inspectors into its facility, and quoted a consumer activist who said the entire plant should be shut down.
While the refusals were committed by the facility’s previous management team when it was under different business name, the article discussed FDA inspections under the current management and the request for recalls of Downing’s products, which are compounded injectable pharmaceuticals. After the article was published, Downing was ordered to discontinue and revamp its operations and recall its products under a FDA Consent Decree.
This incident illustrates what can happen when quality issues spin badly out of control, but also provides an example of how a firm can come around from a Consent Decree and very negative press.
Based on my independent review of the Quality System of this client I can tell that much of the information in the article was biased to some extent against the current owners, as the FDA was never “kicked out” of Downing. And today, Downing has come out of its Consent Decree and is a fully functional compounding company.
How did this happen?
Downing was formed from a number of mergers and capital acquisitions of two other compounding firms. The FDA inspectors did come on site at Downing on two occasions, and wrote the firm on a number of problems with quality, as well as a lack of processes that could have monitored potential contamination and other problems. Following a series of inspections, the company eventually recalled its sterile drug products due to a lack of sterility assurance and ceased sterile operations.
In January, the company was issued a Consent Decree, ordering it to halt manufacturing and distributing its drug products.
The company hired me, and I performed a comprehensive Quality System audit. I advised the management on ways to improving their quality system, monitored their remediation efforts, and certified the facility as a Third Party cGMP expert. As such, I wrote the FDA of my findings and the agency again visited the facility. Within eight months from signing the Consent Decree, the FDA recertified the facility, allowing Downing to resume production and shipping. This is unprecedented in terms of timeline and the effort that was put by the management. Personally, I heard of many companies that decided to permanently shut down their facilities because of the fact that they hired consultants who exploited the situations to their advantage instead of helping the companies in their plights.
Pharmacy Compounding scrutiny
The FDA recently has made pharmacy compounding companies a subject of greater scrutiny, meaning that these firms should look much more closely at their operations, quality systems and sterile processing controls even if they think no problems exist. Downing’s example shows how a company can get caught up in this (even if the problems were started by a previous management team), but also shows how a company can turn the problems around with the right attitude, effort, and a little expert help. Downing invested a great deal of work and money into revamping its production. And with the help of outside consulting support and independent auditing, they could emerge from under a Consent Decree in what probably is record time (nobody really keeps such records).
Synergy Bioscience has the expertise in pharmacy compounding regulatory requirements, such as USP<797>, USP <795>, and FDA regulations such as sections 503A and 503B for sterile,non-sterile, and outsourcing facility for bulk compounding. We can also perform independent audits to your facility and notify the FDA when you are ready for recertification inspection.
And we can offer one more piece of advice: don’t believe everything you read from the press.