The FDA noted that during its inspection last April of the site in Samutprakam, Thailand, an investigator from the agency identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of APIs.
The warning letter includes three main areas where the FDA says the manufacturer has failed to meet certain expectations: failing to ensure reprocessing procedures consistently yield APIs that meet specifications; failing to maintain complete data derived from all testing and to ensure compliance with API specifications and expectations pertaining to data retention; and for failing to prevent unauthorized access or changes to data and to provide adequate controls to prevent omission of data.
The agency specifically chides the company for not removing all of the dirt particles from an OOS (out of specification) product and for failing to explain why the quality unit did not provide proper oversight of cleaning operations, contamination problems, and the adequacy of the reprocessing operations.
The company was also criticized for failing to retain complete raw data to ensure the quality of its APIs. “For example, your firm could not provide electronic raw data supporting your High Pressure Liquid Chromatography (HPLC) testing in your Validation Report,” the FDA said.
In addition, the FDA says “inadequate controls over access to your data raise questions about the authenticity and reliability of your data and the quality of the APIs you produce.”
Novacyl spokeswoman Nathalie Vallier confirmed to us that the “Acetyl Salicylic Acid plant in Bangpoo was inspected by the US FDA in April 2014” and did receive the warning letter late last month and that it “requires additional stronger actions to be taken on.”
“Novacyl is fully mobilized to diligently address the US FDA requests in the coming weeks with the support of a dedicated team of internal and external recognized CGMP experts. We are confident in our capacity to implement a suitable action plan in due time without discontinuing our current sales activities,” Vallier added.
More specifically, the agency says it’s looking for “an in-depth review and evaluation of your reprocessing procedures, and an evaluation of all products made with reprocessed material within expiry.”
This is the second warning letter for Novacyl this year, with the previous one coming for its Wuxi, China-based site back in January. The previous letter was cited in the most recent warning letter and the agency notes that at both sites, investigators “observed similar data integrity concerns.”