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An FDA inspection uncovered a host of GMP deficiencies at a Wockhardt production plant in India, despite earlier attempts by the company to downplay the findings. Read More
French authorities want to ban marketing applications from an Indian manufacturing site after an inspection turned up a whopping 58 GMP violations. Read More
A Puerto Rican drugmaker has landed a 13-observation Form 483 over numerous GMP procedural issues and a lack of oversight at its plant in Salinas. Read More
Sponsors with pending NDAs and ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More
Sponsors with pending ANDAs backed by trials conducted at India’s Semler Research Limited must return to the drawing board because of data integrity issues, the FDA said. Read More