The FDA has begun surprise inspections at compounding pharmacies that, so far, have included four national compounding pharmacies: 1) AnazaoHealth Corp., 2) Central Admixture Pharmacy Services (CAPS), 3) Lee Pharmacy, and 4) PharMEDium Services. According to reports, quality and safety issues were uncovered at each facility.[1]

According to the Washington Post, “The FDA inspection report stated that the company [AnazaoHealth] did not have manufacturing procedures in place to prevent contamination of its drug products and that drug product containers were not clean and sterilized.” In a statement to the Washington Post, AnazaoHealth’s corporate counsel said that compounding pharmacies fall under the authority of states’ boards of pharmacy, not the FDA, and that inspectors from the Florida Division of Drugs, Devices and Cosmetics were also at the facility during the inspection and found no deficiencies.[2]

At CAPS, reports state that inspectors found that, “Personnel failed to take adequate steps to “˜prevent microbial contamination of drug products.’ In one storage room, a bag of citric acid had a hole, which exposed it to possible contamination. Inspectors also found that personnel had failed to properly investigate leaks in a sterile nutritional supplement and potency problems with another drug.”1

At PharMEDium Services, the reports state that inspectors found that, “the facility did not have an appropriate air filtration system, critical to keeping contaminants out of drugs. They also found “˜rust colored build up’ behind a special filter that removes contaminants from the air, and quarter-inch holes in walls by an area where drugs are mixed.”1

The FDA has stated that the agency plans to inspect 30 facilities throughout the next few months, which includes the 11 states that have already been surprised by these visits. Hartley Medical is ready, should we be visited, to accept the FDA representatives with open arms. We will fully cooperate with the agency to ensure patient safety and to guarantee the highest quality sterile pharmaceuticals.

For more information, visit Hartley Medical’s Knowledge Center by clicking here.

[1] Lee, Jaimy. “FDA conducts surprise inspections at compounding pharmacies.” 1 March 2013.

[2] Sun, Lena H. and Kimberly Kindly. “FDA inspects specialty compounding pharmacies in targeted action.” 1 March 2013. Washington Post.