There are those on the marketing side of the pharmaceutical industry who say that you are not really pushing the marketing envelope until you start receiving warnings from the FDA. From a manufacturing perspective, however, the last thing you want is a warning from the FDA...
WARNING LETTER CITES WOCKHARDT FOR CGMP VIOLATIONS
Documentation of environmental monitoring was also delayed for eight months, and when provided it consisted of an employee preparing a drawing from memory for the investigator, the letter said.
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