The U.S. Food and Drug Administration (FDA) has issued a warning letter to the president and CEO of Apotex, Inc., claiming that the agency’s inspection of the company’s Bangalore, India-based pharmaceutical manufacturing facility revealed deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs). The letter specifically cites the company’s failure to (i) “maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards,” (ii) “investigate and document out-of-specification results,” (iii) “include adequate documentation during complaint investigation,” and (iv) “record activities at the time they are performed.”

Noting that the company has committed to hiring a third-party auditor to address these issues, the letter also includes actions this consultant should take. And FDA requests that the company provide a list of all the batches of APIs in distribution and those intended to be shipped to the United States market relying on “missing, inaccurate, or unreliable test data,” as well as take steps to notify the Center for Drug Evaluation and Research Drug Shortages Program to allow FDA “to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.” In addition to barring products from the facility from entry into the United States, FDA indicates that it “may withhold approval of any new applications or supplements listing your firm as an API manufacturer.”