Troubled cancer center in Connecticut handed Form 483 by FDA, again
The Johnson Memorial Cancer Center in Enfield, CT is no stranger to battles with inspection problems, and it was hit with another Form 483 in October, after a string of troubles noted by the FDA.
A number of observations were made, but perhaps the most glaring: staff attaching wipes to a mop handle to try and clean production equipment.
The site was inspected 10 times between Sept. 20 and Oct. 20 of last year.
Bortezomib is used to treat adult patients with multiple myeloma, a cancer of the bone marrow, as well as mantle cell lymphoma. Marketed under the name Velcade, it was co-developed by Millennium Pharmaceuticals and J&J, and landed FDA approval for intravenous injection in 2003, then subcutaneously in 2012. It was later approved in 2014 for pretreatment of multiple myeloma patients. One treatment cycle includes twice-weekly injections for two weeks, followed by a 10-day rest period. Takeda and Janssen co-promote the drug in Japan.
Poor cleaning practices were the reason for the hold, in particular, during the production process. A technician was observed failing to clean the internal screen between batches and used a stainless steel mop handle outfitted with sterilizing wipes to clean the interior of a bioreactor instead of the appropriate mop, which meant that the technician wasn’t able to reach and clean the entire interior, including the back and sides.
A pharmacy technician also failed to clean the septum of two vials of the drug product in between sterile production activities, and the high-efficiency particulate air filter — also known as a HEPA — coverage wasn’t adequate enough, thereby exposing sterile product, the FDA said.
Smoke studies, in which manufacturers must analyze air pattens to ensure that the quality cannot contaminate the drug product, were lacking key aspects in August 2020, February 2021 and August 2021, the agency said.
It’s not the location’s first run-in with contamination problems. In 2014, the site was handed a Form 483 for failing to prevent microbial contamination and mix-ups. Investigators noticed water stain marks in rooms, and the company failed to evaluate air quality, with outside air penetrating through a room used for gowning and preparation before sterilization. HEPA filters hadn’t been properly swapped out and were yellow at the time of inspection, and the firm didn’t evaluate the pressure between clean rooms, something essential to preventing contamination.
Then in 2015, mold and fungus at the site led Connecticut authorities to close the cancer infusion center for months, on top of the manufacturing operations for more than a year. The building was built in 1998, according to the Hartford Business Journal, but state inspectors found more than 50 serious violations at the hospital and its treatment centers, which included staff blatantly ignoring problems that included mold and fungus. Despite the indication that staff was aware of the problems, they weren’t discussed publicly, according to the meeting minutes.
A representative from the center did not return a request for information by publication time.