FDA Cites Pharma Manufacturers in India and Germany for CGMP Violations
The Food and Drug Administration said it may refuse imports from pharmaceutical manufacturers in India and Germany, in separate warning letters sent to the companies in April and May. FDA said an inspection of a Sun Pharmaceutical Industries manufacturing facility…
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in Gujarat, India turned up violations of CGMP requirements for both finished pharmaceuticals and active pharmaceutical ingredients (APIs) (here). It also told SANUM-Kehlbeck that an inspection of the pharmaceutical manufacturer’s facility in Hoya, Germany found violations of CGMP requirements for both finished pharmaceuticals and APIs, as well as a failure by the company to register with FDA (here). The agency told both companies that their drug products are subject to refusal of admission because of the violations.