The US regulator detailed its ongoing concerns about Interpharm’s active pharmaceutical ingredient (API) manufacturing plant, which is in the Prague suburb Modrany, in a warning letter published last week.
Foremost among the criticisms is that Interpharm’s response to the thousands of instances of data manipulation uncovered last October does not make clear how access to laboratory test results has been restricted.
“According to your response, you restricted access and permissions in the Empower 2 automated data system. However, your response does not demonstrate how the specific controls you have implemented prevent deletion or alteration of data, nor have you shown how you will ensure that these permissions are documented, implemented, and followed.”
Chromatography manipulation
The US Food and Drug Administration (FDA) said it has concerns about Interpharm’s efforts to make sure chromatographic analysis of APIs is conducted appropriately, explaining that inspectors observed instances of results being ignored or deleted without justification.
“According to your response, you scheduled training on manual integration for all analysts who use Empower-2 software. You have not shown how you will ensure that your test methods are appropriate to determine whether your APIs conform to established standards and specifications.”
Interpharm has 15 days from receipt of the letter to respond.