FDA warns two manufacturers from China, India for GMP lapses
- A Chinese drug supplier has fallen afoul of the Food and Drug Administration for an array of GMP violations, including shipping to the U.S. active pharmaceutical ingredient (API) produced by a banned third-party manufacturer.
- Lumis Global Pharmaceuticals regularly relabeled gabapentin API as manufactured by Lumis when it had in fact been manufactured by contracted companies, a recently posted warning letter from the FDA said.
- The FDA placed Lumis on its import ban list last month as a result of the deficiencies uncovered in a September 2016 inspection of the company's Wuhan plant.
Lumis triggered the FDA's ire by copying the certificate of analysis for API produced by contract manufacturers and then pasting it on Lumis letterhead. Under section 502(a) of the Federal Food, Drug, and Cosmetic Act, this constitutes misbranding — just one of a slew of regulations foreign drugmakers shipping product into the U.S. have to meet.
In addition to banning imports from Lumis, the FDA recommended the company hire a CGMP consultant to bring it into compliance.
So far in 2017, the FDA has issued warnings to 14 drug manufacturers, including the one to Lumis and another recently posted letter to the Indian manufacturer Badrivishal Chemicals & Pharmaceuticals.
FDA inspectors found Badrivishal failed to test water from a nearby river that it uses as a drug component and to clean its equipment. In addition, Badrivishal did not adequately investigate possible contamination.
Badrivishal was placed on the FDA's import ban in December 2016.
Six Chinese and four Indian firms have been sent warning letters this year, reflecting a continuation of the stepped-up FDA oversight on manufacturers located in the two countries.
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