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After the FDA clamped down on its facilities most of the year, Lupin has received clearance from the agency to produce drugs again at its site in Goa, India. Read More
A response to a Form 483 is not a routine or informal communication and should be given the same attention and care you would give to defending your company from a federal indictment — because that’s what a 483 actually is. Read More
The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
The FDA issued Spanish API maker Interquim a warning letter for failing to establish adequate cleaning procedures and maintain quality records data in violation of GMP standards. Read More
The FDA issued a Form 483 to Baxalta after an inspection revealed a litany of observations including two from an earlier inspection that were not corrected. Read More