The European Medicines Agency has found issues at the plant of an Indian API maker that the FDA hit with a warning letter some years back.
In a recent posting, the EMA noted a risk of cross contamination of products during a November inspection by the U.K. of a Micro Labs plant in Hosur, India. The plant produces tablets and capsules, the agency noted.
While only the one violation was cited, regulators found the problem severe enough to withdraw the company’s GMP certificate for the plant and suggest that countries recall its products if they are not essential to patient supply. The agency also is prohibiting any new products for which there are alternatives.
The FDA in 2015 cited a Micro Labs plant in Bangalore with a warning letter, mostly for data integrity concerns. According to the FDA, Micro Labs personnel failed to ensure laboratory records included complete data, to exercise appropriate controls over computer systems and record or to justify any deviations from required laboratory control mechanisms.