An Indonesian firm was warned by the US Food and Drug Administration for failures in product testing and method validation, among other breaches of current good manufacturing practice.
In a November 2019 inspection of PT. MegaSura Mas, FDA inspectors found that some assays conducted for batch releases of an over-the-counter product were performed after the batches were released.
“This discrepancy on batch release documents demonstrates a concern regarding the validity in your CGMP records,” wrote FDA in the warning letter dated 24 August 2020.
According to the warning letter, the firm also used an assay testing method for the active ingredient in the finished product that was not a US Pharmacopeia method, nor was it validated by high-performance liquid chromatography.
The product produced by the firm was redacted in the letter.
Another shortcoming identified by the inspectors was a failure to conduct “At least one test to verify the identity of each component of a drug product;” instead, said FDA, PT. MegaSura Mas relied on certificates on analysis from suppliers of active pharmaceutical ingredients.
The quality unit maintained by PT. MegaSura Mas had multiple shortcomings, according to FDA inspectors.
Finally, said FDA, the firm’s stability program lacked protocols for accelerated and long-term stability testing.
In another warning letter, FDA cited California-based Calvin Scott & Company for deficiencies found during a March 2020 inspection of the firm’s Albuquerque, N.M. plant.
The firm had not established a dedicated quality control unit, said FDA: “Multiple personnel in your manufacturing operation had the authority to perform quality control unit responsibilities, including release of drug products for distribution.”However,” said the agency, “there is no assurance that you have appropriate separation of approval or rejection authority for final drug product release from personnel performing repackaging operations.