Cdymax Pharma has been slapped with a warning letter from the FDA outlining two observations against the Bangalore, India-based API maker, both linked to testing shortfalls.
The letter comes in response to an earlier Form 483 that the FDA issued after inspecting Cdymax's facility from April 21-25.
During the inspection, the FDA found Cdymax did not properly investigate multiple out-of-specification (OOS) results and laboratory incidents during the testing of various samples, including raw materials, starting materials and stability samples, the regulator said.
Cdymax was also cited for failing to ensure that all specifications, sampling plans and test procedures for the drug ingredients made at its plant were scientifically sound and appropriate.
The company, the FDA said, has had about 1,500 lab incidents since 2023 that involved out-of-spec results and other significant analytical events such as equipment failures.
In one instance, the company conducted two sample preparations of a stability sample related to an “unknown peak” observed in a product. Cdymax retested the samples in their original vials and in new sample vials.
“The results of all four retests were also OOS for an 'unknown peak,'” the FDA said. “Subsequently, you performed a third test with fresh sample preparations and after receiving passing results, your firm invalidated all earlier test results.”
Cdymax ultimately hypothesized that the unknown peaks could have been caused by "'sample solution contamination during preparation,'" the FDA said.
But the company's investigation lacked scientific and thorough root cause analysis and failed to identify the contaminant, its origin or the cause of its presence in Cdymax's product samples, the FDA explained.
“Because you did not determine a definitive laboratory error, your investigation should have included a manufacturing investigation,” the agency said.
That batch, the FDA noted, remains within U.S. distribution “and is only one example out of numerous inadequate investigations observed during our inspection.”
In light of the observations made during the site visit, the FDA has recommended Cdymax enlist a current good manufacturing practices consultant to evaluate its operations and help raise standards at the Bangalore plant.