After rising to prominence during the COVID-19 pandemic, South African drugmaker Aspen Pharmacare has landed in the FDA's crosshairs thanks to a recent inspection that uncovered problems at one of the company's production plants.
Aspen, the largest drugmaker on the African continent, was slammed last month in a warning letter by the FDA citing sterility issues that could lead to microbial contamination. The FDA posted the document on its website Tuesday.
The rebuke follows a Sept. 9-17 inspection of the company's manufacturing site in Gqeberha, South Africa. In assessing the site's conditions, the agency concluded the company failed to adopt scientifically sound laboratory controls needed to meet regulatory standards. The plant that was under review specifically produces eye drops and other sterile medicines.
The warning letter was issued to Aspen on Feb. 24. Earlier in the month of February, the agency placed certain Aspen products on its Import Alert list, according to the document.
Digging deeper into Aspen's manufacturing infractions, the company failed to perform impurity testing prior to the release of an unspecified product, according to the FDA. Further, the company didn’t establish scientifically justified specifications to monitor impurities during stability testing of products containing two particular active pharmaceutical ingredients used in eye drops, the FDA said in its letter.
During the inspection, the FDA also observed operators using their gloved hands rather than appropriate sterile tools to remove jammed bottles from a product line. Workers were also seen blocking airflow from a HEPA filter by placing their hands directly over open sterilized bottles without removing them from the aseptic filling line.
These issues were not isolated problems, as the company told the FDA that it identified contamination in two media fill batches produced on a pair of aseptic filling lines at the facility back in 2022.
“You identified the root cause as poor aseptic behavior,” the agency said in its letter. “These contamination events along with the poor aseptic practices observed during our inspection indicate your aseptic manufacturing operations may lack adequate control.”
FDA inspectors also noted that a large door leading to the outside was left open on “numerous occasions” for ventilation purposes. This practice could expose empty sterile containers to exterior conditions, the FDA said.
Aspen was additionally cited for not having appropriate controls over computer or related systems to ensure that only authorized personnel can make changes in master production and control records. The FDA said Aspen also failed to institute an adequate system for monitoring environmental conditions in aseptic processing areas at its plant.
Aspen has subsequently suspended production of all drugs for the U.S. market.
Aspen hit the international scene during the COVID-19 pandemic when it secured a license to distribute, price and brand Johnson & Johnson’s COVID-19 shot in Africa. However, the deal eventually soured due to a lack of demand for the vaccine.
Undaunted, the company in late 2023 expanded its global footprint with a $100.3 million agreement to buy Sandoz’s China operations, which came shortly after Sandoz was spun off by its parent Novartis.
Aspen was also tapped by Novo Nordisk in 2023 to help produce human insulin for Africa, using—in part—some of the sterile infrastructure the company previously established to make COVID vaccines.