Late this week, the FDA dished up a pair of manufacturing write-ups, with one going to high-flying Samsung Biologics and the other to India’s Nectar Lifesciences. In Samsung’s case, the regulatory wrist-slap marks a rare blemish on the company’s otherwise impressive production record.
After inspecting Samsung’s Incheon, South Korea, manufacturing site in August and September, the FDA chided the CDMO for problems related to data and production controls, machine validation shortfalls, poor facility maintenance and lackluster quality control.
In a six-observation Form 483 filing, FDA investigators noted that Samsung’s Manufacturing Scientific Analytical Technology (MSAT) laboratory—used in support of application submission testing data—had “inadequate controls over data integrity.”
While Samsung completed internal data integrity assessments for each drug application, “there is no means of determining with absolute certainty the true reliability of all test data," the FDA officials wrote. The agency noted that Samsung hadn't contracted for a "third-party independent assessment" of its data.
It’s unclear how use of the MSAT lab in support of submission data could affect any commercially marketed products, the agency said.
In addition to its MSAT lab problems, Samsung was dinged by the FDA for failing to establish or follow appropriate written control procedures for its manufacturing.
Further, Samsung’s quality unit failed to ensure equipment was being maintained and used within its validated state, the FDA went on to say.
Finally, the FDA cautioned that Samsung’s facilities are not adequately maintained, flagging a dislodged ceiling port, broken doors and a missing seal on a loading ramp dock—all of which create “a potential entry point for pests to enter the facility,” the FDA said.
Samsung, for its part, says it’s taking the FDA’s concerns seriously and has “developed a comprehensive plan” to address the manufacturing shortfalls swiftly in tandem with the FDA.
“There’s no impact on the quality of our products or the safety of patients,” a company spokesperson added over email. “We take compliance very seriously and will do everything we can to address any concerns as quickly as possible.”
When it comes to Nectar’s regulatory rebuke, the FDA issued a two-observation Form 483 following an inspection of the drugmaker’s facility in Himachal Pradesh, India, between March 2 and March 10.
The FDA scolded Nectar for failing to establish written procedures meant to thwart microbiological contamination of sterile drugs. Furthermore, Nectar failed to set up an effective system for monitoring environmental conditions in aseptic processing areas, the FDA said.
Because the FDA uncovered similar problems at Nectar’s plant back in 2014, “[r]epeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate," according to the agency.
Now, if Nectar wants to continue producing drugs bound for the U.S., the FDA is recommending the Indian drugmaker enlist a good manufacturing practices consultant.
While Forms 483 aren’t entirely uncommon in the realm of drug manufacturing, Samsung’s write-up marks something of a blip on an otherwise impressive production record.
The company has been on a massive expansion tear in Korea over the past several years, with the company recently indicating it was ready to kick off construction of its latest facility, dubbed Plant 5. Samsung is pouring 1.9 trillion South Korean won ($1.46 billion) into the project, which will add 180,000 liters of capacity to its complex in Incheon.
Elsewhere, the Korean CDMO continues to rack up deals with an impressive Rolodex of pharma bigwigs including Pfizer and Bristol Myers Squibb.
Editor's note: This story has been updated with comment from Samsung Biologics.